COMPASS Pathways News | December 2019 Issue
The COMPASS family has grown. Our Christmas party this year was a large, noisy and joyful occasion - and as our team, advisers, partners, investors and supporters chatted, I felt deeply grateful to all of you who have trusted our intentions, vision and skills, were generous with your time and expertise, and joined us as we work to transform mental health care.
As another year comes to an end, I wanted to share my reflections on 2019 at COMPASS.
It feels good to have reported our first clinical data from our healthy volunteers study, at the annual meeting of the ACNP (American College of Neuropsychopharmacology) in December. In addition to creating regulatory quality data on the short- and long-term safety of psilocybin, we explored the safety and feasibility of 1:1 therapeutic support with several simultaneous sessions. If further supported by regulators, this model could expedite research and eventually improve patient access to innovative treatments. The healthy volunteers study was completed in less than a year, an accomplishment made possible by the dedicated team at the Institute of Psychiatry, Psychology & Neuroscience at Kings College London.
James Rucker from IoPPN, presenting at ACNP
Our core clinical program of psilocybin therapy in treatment-resistant depression is progressing well. We now have 18 sites actively recruiting patients, across Europe and North America. In addition, a number of investigator-initiated studies for other indications of significant unmet need have received regulatory approval and will start in 2020. We have learned, and continue to learn, a huge amount about running regulated clinical trials with psychoactive substances. This includes best practice around manufacturing and handling a scheduled substance; therapist training; patient recruitment; and psychological support and care.
It’s not easy for patients with mental illness to demand an increase in research funding and equitable access to mental health care - these patients need advocates. This year we partnered with the US Depression and Bipolar Support Alliance (DBSA), a peer-support advocacy organisation, to better understand the realities and needs of patients living with depression and other mood disorders. It was a highlight of the year for me to participate in a joint meeting of the DBSA and the FDA (US Food and Drug Administration) on patient-preferred outcomes and their role in the regulatory decision process. With the emergence of a new class of psychoactive rapid-acting antidepressants, such as esketamine and psilocybin, established methodology and existing psychiatric scales might not be able to reflect the real value these new treatment paradigms create for patients, families and health systems. To understand this better, we look forward to working closely with regulators, researchers and patient groups on these and similarly challenging questions in the new year.
It’s been a tremendous year for the field of psychedelic science. We have seen psilocybin therapy becoming more widely known and accepted: new psychedelic research centres have been established at Imperial College London and Johns Hopkins University, with combined pledges of over $20m; and new conferences of the International Society of Research in Psychedelics and European MIND Foundation have launched with great success. We were delighted to see that, a year after we received Breakthrough Therapy designation for our psilocybin therapy for treatment-resistant depression, the FDA granted another Breakthrough Therapy designation for psilocybin, this time in major depression to Usona Institute. This highlights the regulatory support for new approaches to caring for patients suffering with depression. Just last month we had a thoughtful and constructive four hour consultation with the European Medicines Agency (EMA) and European payors (EUnetHTA – European Network for Health Technology Assessment) on the evidence required for psilocybin therapy to be reimbursed and integrated into national health systems, so all patients in need can access it regardless of their ability to pay. The outcomes of our conversations with patient advocacy groups, regulators and payors will further inform our clinical development programme for the next few years.
This year we have also witnessed the growth of interest in psilocybin from entrepreneurs and investors. According to LinkedIn, there are now more than 300 new companies and platforms in the psychedelic space, mostly focusing on recreational consumer-oriented markets. As the field grows, the division between recreation and medical use will become clearer as these different models require different resource and funding, skills and risk tolerance. Our business development team has been hard at work, looking at investment and partnership opportunities outside of our current programmes, with a focus on ideas that offer transformative treatments and new models of patient care. The most successful decriminalisation and legalisation efforts are unlikely to make a dent in the mental health crisis we are facing. The research in new therapeutic targets and novel treatments will continue within the constraints of the current regulatory and healthcare systems. For the first time in decades, psychiatry has a real shot at having approved treatments that not only alleviate the symptoms, but empower patients, and we simply cannot afford to miss that chance.
And so to 2020. Next year we aim to complete our phase IIb clinical trial of psilocybin therapy for treatment-resistant depression, and to analyse and report results from over 20 pre-clinical and early phase clinical studies.
Most importantly, we will also focus on developing our strategic academic and business partnerships, and sponsored research, to create clinical research centres with deep experience and understanding of psychedelic science and therapy. I hope that 2020 will be the start of the decade in which we see a real transformation in mental health care and come closer to our vision of a world of mental wellbeing.
COMPASS London team 2019
We wish you and your loved ones all the very best for the holidays and the New Year. As always, please share your reflections, ideas and questions with us.
With warm holiday wishes,
COMPASS Pathways and King’s College London announce results from psilocybin study in healthy volunteers
‘A change is in the air’ – ISAD 2019 symposium
It is estimated that 100 million people around the world suffer with depression that is not helped by existing medication. As a community, we need to do something about this. That’s why COMPASS brought together some of the world’s leading experts at the 2019 International Society of Affective Disorders (ISAD) conference in London to discuss the potential for psilocybin therapy in helping people with treatment-resistant depression.
The meeting was chaired by Professor Allan Young, Director of Kings College’s Centre for Affective Disorders, who was joined on a panel by Dr David Erritzoe of Imperial College, London, Catherine Bird and Dr James Rucker from King’s College London, and me, COMPASS Pathways’s Chief Medical Officer.
The need for innovation
The tone of the panel was set by Professor Young, who described the focus on revitalising the field of treating depression, and moving away from ‘another SSRI’, the class of drugs which, many believe, provides insufficient efficacy for many patients with depression. The audience was reminded of the history and neuroscience of psilocybin, how clinical research to date suggests a potential benefit in treatment-resistant depression, and the importance of ensuring the safety of those taking part in the current clinical trials that are actively enrolling patients.
Why set and setting is so important to psilocybin therapy
Of particular interest was our discussion on the importance of ‘set and setting’ during psilocybin therapy. Catherine Bird described the significance of context in a psychedelic treatment experience, how to run clinical trials when there’s no approved ‘model’, and managing this unconventional clinical approach in a safe way. Dr Erritzoe expanded on the effect of music during a psychedelic experience, sparking a debate about the subjectivity of music tastes and the potential for future investigators to be “more creative” about all elements of psilocybin therapy’s context.
Taking a traditional approach for a non-traditional drug
The positive discussion concluded with Dr Rucker attesting that there was “a change in the air” in reference to the number of studies now being conducted in psychedelic therapy, and stating his belief in the potential of psilocybin as a medicine. I reiterated that “the path forward is clear” with the need to complete a full clinical development programme with psilocybin therapy, to the highest standards. With fewer and fewer clincal trials being initiated for new drugs to tackle the unmet need in depression, I highlighted the importance of taking a “traditional approach for this non-traditional drug”.
We thank everyone who attended the meeting at ISAD, and especially our panel members and Chair for a great discussion. We hope it will have answered some of the questions around setting up trials in psilocybin therapy and explained why so many of us believe this is a highly promising innovation for mental health challenges like treatment-resistant depression.
COMPASS Pathways News | July 2019 Issue
Here are highlights of our activities in the first half of 2019 that we hope will move us closer to our goal of improving mental health care for as many as possible.
The resurgence in psychedelic research began two decades ago, with a handful of dedicated individuals and institutions studying the potential impact of substances such as psilocybin, MDMA and ketamine, in mental health care. Now, in 2019, psychedelic therapy is taking centre stage, with discussions on the subject taking place at high-profile global events such as TED and the World Economic Forum in Davos, as well as at mainstream healthcare and life sciences conferences.
We welcome this growing interest and are fortunate to collaborate and work with so many people who share our ambition of better care for those suffering with mental illness. Our commitment to our mission is as strong as it was when we began; we want to accelerate patient access to evidence-based innovation in mental health. Psychedelic research is a good place to start.
Treatment-resistant depression study in progress
Thirteen of our clinical trial sites are now active: we have three sites in the UK, three in the Netherlands, three in the USA, two in Spain, and one in each of Ireland and Canada. Further sites will be opening over the next few months. In total, our sites will be recruiting 216 patients with treatment-resistant depression, from across Europe and North America, to take part in this Psilocybin Therapy phase IIb trial.
As part of the trial recruitment process, potential participants are very carefully screened, by our trial sites and independent eligibility reviewers, to ensure their eligibility for the treatment. Our training of therapists is equally rigorous. We have now trained 65 therapists and assisting therapists in Europe, US and Canada. For a map of our current sites, click here.
Healthy volunteers study completed
We have completed our study of healthy volunteers, looking at the short- and long-term effects of medium and high dose psilocybin on social, emotional and cognitive functioning, compared with placebo. With 89 participants, this is the largest psilocybin study ever done. We are now processing the data and will be reporting full results later in the year.
Dr James Rucker, study clinician at King’s College London where the trial took place, said “To hear participants speaking afterwards about their deeply positive and heartfelt experiences was an emotional experience for me. ‘Blown away’, ‘profound and amazing’ and ‘years of the deepest psychotherapy’ were some of the phrases that come to mind. There was immense gratitude for the experience and for the attention to detail of the set-up and the study team.”
In addition to progressing our own studies with psilocybin, we collaborate with select academic institutions and researchers, supporting research that could help patients and lead to a change in mental health outcomes. We provide our GMP (good manufacturing practice) psilocybin for these studies, free of charge, in exchange for the right to use the safety data generated. We are currently working or in discussion with 20 research teams on studies covering a broad spectrum of topics.
It is critically important that scientific research in this area continues, given the large unmet need in so many mental illnesses. At the same time, any innovation or breakthrough has to move out of the lab and into the reach of patients. We are committed to developing any promising results from early studies into the robust, large-scale research programmes required to generate the evidence needed by regulators, payers and health systems.
Funding our next phase of growth
We have raised $35 million to date, from a number of investors, all of whom are committed to our mission to improve patient access to innovation, and to see a shift in the way in which mental illness is treated and managed. We begin a further funding round later this month, and will use the money raised to drive our next phase of growth, operationally and in R&D. Our R&D work will include our own research, as well as any development programmes that emerge from our academic collaborations. Large-scale clinical trials require significant investment but are the only route by which we can move from innovation to patients.
Our team is expanding; we now have over 20 talented and committed people in our UK and US offices, as well as a thriving internship programme. This summer we welcomed interns from MIT, UPenn, UCL and Cambridge, working across different functions, including R&D, Clinical Operations, Patient Access, Business Development, and Technology.
We are already seeing the benefits of the Breakthrough Therapy designation that the FDA has given to our protocol of Psilocybin Therapy for treatment-resistant depression. FDA experts are helping us with our Clinical Development Plan for Psilocybin Therapy, as well as our plans for additional studies. And we are continuing to talk to payers, insurers, and patient advocacy organisations about patient access, and to explore ideas for how we make Psilocybin Therapy available to as many patients as possible.
While Psilocybin Therapy for treatment-resistant depression remains our priority and focus, our R&D team are also looking at other new compounds, innovative technologies and treatment modalities that might help patients for whom existing treatments don’t work. We are committed to bringing innovation to these patients as quickly as we can, and to understanding how we get people well and keep them well.
If you’d like to know more about what we are doing or have any comments about COMPASS Pathways News, please get in touch with us at firstname.lastname@example.org.
COMPASS Pathways News | December 2018 Issue
As 2018 draws to a close, we reflect on another busy year and share our highlights of the last few months with you.
We have continued to make good progress since our last update: beginning patient recruitment in five of our treatment-resistant depression trial sites; gaining approval and breakthrough therapy designation for our trial from the US Food and Drugs Administration (FDA); reaching the halfway point in our healthy volunteers study; securing £25m in funding; and convening the first meeting of our Scientific Advisory Board.
We receive emails from so many people who are suffering, or are close to someone who is suffering, with treatment-resistant depression. These stories motivate us all every day at COMPASS. Our mission – accelerating patient access to evidence-based innovation in mental health – remains critical while the incidence of depression and other mental health challenges continues to rise. More than 100 million people have treatment-resistant depression (TRD) and depression remains the leading cause of disability worldwide. We simply cannot ignore this and are determined to do our part in alleviating it. We remain focused on developing Psilocybin Therapy for the safe and effective treatment of patients with depression, for whom existing treatments do not work.
Treatment-resistant depression (TRD) trial
Our phase IIb clinical trial for Psilocybin Therapy for treatment-resistant depression has now been fully approved in the UK, the Netherlands, Canada, the US, and Ireland. Further approvals are expected in additional European countries over the next few months. Patient recruitment has begun in trial sites in the UK, the Netherlands, and Ireland.
In October, we held an Investigator Meeting and therapist training for our North American sites. These sites, across the US and Canada, will begin patient recruitment in the first quarter of 2019.
Breakthrough therapy designation
In October, the FDA awarded breakthrough therapy designation to Psilocybin Therapy as a potential treatment for treatment-resistant depression. Breakthrough therapy designation is given to therapies for which preliminary clinical evidence shows a potential substantial improvement over available treatments. This is a strong endorsement for the potential of Psilocybin Therapy and one that will increase the chances of getting this treatment to the many people suffering with treatment-resistant depression. The designation means the FDA will be committed to supporting our clinical development programme and will work closely with us to ensure the process is as efficient as possible.
Breakthrough therapy designation is also a mark of recognition for the vision and extraordinary work of generations of psychedelic researchers and therapists before us.
Healthy volunteers study
Our healthy volunteers study is halfway through. The study is taking place at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London, and explores the short- and long-term effects of medium- and high-dose psilocybin on social, emotional and cognitive functioning, as compared to placebo. The study also provides a platform for therapists in our TRD trial to support volunteers under the guidance of our expert therapists, as part of their professional training.
We expect to complete the healthy volunteers study in the first half of next year and to report findings in the second half.
We have completed our Series A financing round, raising £25m from a group of investors who share our commitment to bringing Psilocybin Therapy to as many patients as possible. The funds will enable us to complete our healthy volunteers study and phase IIb trial.
Scientific advisory board
In November, we held the inaugural meeting of our scientific advisory board (SAB), a group comprising experts in neuroscience, psychiatry, neuropsychopharmacology, and regulatory science. With our SAB, we have begun to refine our clinical development plans and to explore ideas for additional studies in the future, to complement our work on treatment-resistant depression.
Looking ahead to 2019
Our progress and our achievements have been made possible by the dedication of our strong in-house team.
Our team continues to grow, and we are delighted that Hans Eriksson will be joining COMPASS in January as our new Chief Medical Officer. Hans was most recently Senior Director, Clinical Research for Depression and Pediatrics at H Lundbeck. He brings a wealth of experience in taking medicinal products to patients and we look forward to working with him as our clinical development programme continues. Ekaterina Malievskaia, COMPASS co-founder and current Chief Medical Officer, will take a more strategic role from 2019, overseeing R&D and our therapist training programme.
We enjoy a vibrant internship programme at COMPASS. This year we had 11 interns from leading European and US academic institutions, spending on average three months at COMPASS, and learning and contributing to different teams - from clinical trial management and operations, to market access, business development and fundraising. We will continue this programme in 2019.
In addition to our talented colleagues and enthusiastic interns, we are fortunate to work with an exceptionally skilled and dedicated group of advisors and partners. We are all excited about the next few months and each step that takes us closer to our goal of accelerating access to help patients.
In 2019, we will complete and report out on our healthy volunteers study. We also aim to complete recruitment for our treatment-resistant depression trial. While we are not pre-empting what the science will tell us or what the results of the trial will be, we have started the critical and complex work on market access strategy, so that we can be ready to bring Psilocybin Therapy to patients without delay and in a way that makes it accessible and affordable to as many people as possible.
In the spirit of the holiday season and on behalf of our board members, scientific advisors, investors and supporters, COMPASS has made a donation to One Mind, a US-based non-profit organisation dedicated to accelerating research in mental health though the principles of large-scale open science. We support and share their goals which are very much aligned to the work we are doing at COMPASS.
With only a few days left in 2018, we wish everyone a very happy holiday season, and all the best for the New Year.
If you’d like to know more about what we are doing or have comments about COMPASS Pathways News, please get in touch with us at email@example.com.
Navigating mental health: COMPASS Pathways’ psilocybin research programme
Article written for the MAPS Bulletin Winter 2018
By Ekaterina Malievskaia, MD, MSc
Chief Medical Officer and Co-founder
I first came to psychedelic research from a very personal experience with the limitations of psychiatry. I am a physician. George Goldsmith, my partner in life and business, has worked on complex regulatory and ethical issues of public-private collaboration. But despite our backgrounds, nothing prepared us for the devastation caused by the failure of the mental health care system when my son became ill. Even when the best doctors in the best institutions gave up on us, I kept looking for solutions. As we shared our story with friends and strangers, we realized that all of us are affected by the mental health crisis. And in the depth of our despair, we were still aware of how fortunate we were: we had resources and connections, and we could understand and assess the risks and benefits of emergent evidence for novel approaches. We resolved to make a difference for families who are in dire need of better treatments.
The early days
George and I were impressed by the vision and scientific rigor of the researchers at the Multidisciplinary Association for Psychedelic Studies (MAPS) and the Heffter Research Institute. Immediately after our first Heffter Board meeting in 2014, we offered not only financial support to the field, but help with regulatory strategy so that patients could benefit sooner. Despite significant challenges, we remain true to these commitments four years later.
In 2015, we created a US/UK non-profit, COMPASS, to support a pragmatic research project into psilocybin for psychological distress in hospice on the Isle of Man. Margaret Simpson, the visionary CEO of the hospice center, secured the support of the government, and together we received permission to train the first group of psychedelic therapists with psilocybin. There was only one obstacle: the psilocybin was not yet available from the Usona Institute or from the University of Wisconsin, both of which were also doing psilocybin research. Rather than wait, some of COMPASS’ Board of Trustees members recommended that we manufacture psilocybin ourselves. Given our mission, and uncertainty about the availability of psilocybin made under current Good Manufacturing Practices (cGMP), we followed their recommendation.
From its establishment in 2015 through its dissolution in 2017 (more on this later), COMPASS was 100% funded by George and me. No other donor funding was ever raised. We anticipated that if we followed the published process of synthesis, the cost of manufacturing would be in the range of £350,000 to £750,000 ($460,000 to nearly $1 million). We set out to create our supply for research in Europe. However, while we shifted our focus to the manufacturing of GMP psilocybin, the hospice CEO retired, the political leadership of the Isle of Man changed, and the opportunity passed.
The process of synthesis and formulation turned out to be much more complex and expensive than anticipated. We funded this work out of our personal funds, and the ever-rising cost was simply outside of our reach. That led George and me to seek legal advice to establish a drug manufacturing company eligible for tax credits under a UK government program that helps underwrite the cost of medicine research and development. That option, as well as other government incentives, is not available for non-profits. We formed that company, COMPASS Pathways Technologies Ltd, in June 2016.
In August 2016, Heffter researchers asked us to write a regulatory commentary on the upcoming publication of two landmark studies of psilocybin for cancer-related distress. Our advisor, the former head of the UK regulator, the Medicines and Healthcare products Regulatory Agency, Professor Sir Alasdair Breckenridge, agreed to do this. Heffter researchers also agreed for us to share the studies with the European Medicine Agency’s Scientific Advice Working Party in October 2016, a few weeks prior to the studies’ publication. The meeting with the EMA team was pragmatic, collaborative, and sobering. The regulators acknowledged the early evidence of efficacy, but encouraged us to focus on the indication of major depression instead. We shared the details of these discussions with both Heffter and Usona to help inform their regulatory strategy and further study designs.
We took a sabbatical to consider our options. It was clear there were no political barriers to developing psilocybin as a medicine should the science meet regulatory standards. If we wanted to explore the therapeutic potential of psilocybin for depression, we were expected to take the traditional clinical development path, just like any other Investigational Medicinal Product (IMP). This meant we needed to go back to basics, starting with preclinical and simple dose-finding studies. It also meant the overall cost of development of psilocybin for the indication of depression would be over £100 million ($130 million).
We knew we would not be able to raise the necessary funds through donations since the clinical research was still in an early stage, and the indication of depression is among the most challenging ones. If we were to spend over £100 million on drug development, we wanted the solutions to be affordable, scalable and sustainable. In February 2017, we made the decision to establish a for-profit life sciences company. We renamed the for-profit drug development company to COMPASS Pathways. We started the process to wind-down the non-profit shortly thereafter. The only asset that we developed that had value following the EMA advice to focus on the indication of treatment resistant depression was the name and the branding work we commissioned. While this was of no value to anyone else, we purchased this asset for the same amount it cost to develop. This was independently reviewed and approved by the non-profit board of trustees.The non-profit was only funded by us personally and had no outstanding obligations to others, so the transition to for-profit was legally and logistically straightforward.
Manufacturing and patenting
While psilocybin is a naturally occurring molecule, psilocybin as an Investigational Medicinal Product or IMP is a regulatory entity that includes a detailed description of a GMP-compliant, scalable and reproducible manufacturing process; associated preclinical data; and ongoing safety data collected in clinical trials. The IMP can be thought of as a product’s fingerprint, so that regulators can recognize the safety and efficacy evidence gathered in the clinical trials as it relates to this unique product. The creation of an IMP is an extremely complex and expensive process that requires sustainable funding and a serious multi-disciplinary team effort. Based on our experience and the regulatory input from EMA, we now estimate that the development process will continue through marketing authorization and cost over £3 million (nearly $4 million).
In the process of synthesis, formulation and creation of preclinical data, we reached out to the researchers at Heffter and Usona with offers to share experience and ever rising cost, the last conversation being at PS17 in Oakland. Shortly after, the initial phases of the synthesis and formulation were completed, and psilocybin became the Investigational Medicinal Product. From that point on, for the reasons of data consistency, there was no regulatory acceptable mechanism of “sharing” it other than through standard licensing agreements for the use of IMP. This is the way clinical research regulation works around the world.
As the previously published synthesis processes did not scale to meet regulatory standards, we had to invent our own process. As he would have done for anyone who would have asked for his help, David Nichols advised our manufacturing team. With his support our team has solved over 60 distinct technical problems in the synthesis and formulation process. Some of these inventions became the basis for our manufacturing patents. In general, patents provide an opportunity for an organization willing not only to take a significant financial risk to recoup the expenses, but more importantly, to ensure integrity of the data collected before and after the approval.
Our patents do not preclude others from creating a range of different solutions for the synthesis and formulation of psilocybin; nor do they preclude the use of naturally occurring mushrooms, extracts, or any other products created by alternative synthesis and formulation routes. Equally, our patents do not prevent other clinicians from using our product or any psilocybin-containing products in conjunction with the types of therapy or psychological support they judge to be helpful, as long as it does not jeopardize patient safety. Lastly, neither our patents, regulatory strategy, nor pricing strategy have an impact on the practices of the underground community of practitioners in nonclinical settings.
Our exclusive contract with the drug manufacturer does not prevent others from choosing among many different competing manufacturers through the standard Request for Proposal (RFP) process. The advances of science may now offer new creative solutions for the synthesis and formulation of psilocybin with new partners for those who are willing and able to spend the time, effort, and funds to create an alternative psilocybin-based IMP.
While we have created the supply of psilocybin for our own research, we have made the unusual decision to share it with qualified independent researchers free of charge in exchange for being able to use their safety data. This is not a commercial decision, but yet another way to accelerate the generation of clinically relevant evidence that may ultimately improve patient outcomes.
This process has proven to be challenging at times. As we have learned, university legal departments and technology transfer offices are vigilant about the potential Intellectual Property (IP) that might be created in the process of investigator-initiated studies. This IP, despite the best intentions of the researchers, does not belong to the scientists, who have limited say in how it is used by their institutions. In the event of IP creation, Technology Transfer Offices have a legal obligation to license it out to the ‘highest bidder’ with the most aggressive and scalable business model that will generate the most return for the academic institution. Even though such IP would be created by independent researchers with our IMP, in order to use the invention, we still have to compete with other commercial entities who might have different ethics or commercial goals.
This is an important consideration for the signatories of the Statement on Open Science and Open Praxis who work for academic institutions, as they need to align with their institutions on terms of IP licensing. The core principle of the statement is that knowledge created by signatories is open to all - that is, the knowledge is to be given away unconditionally by relinquishing researchers’ rights to protect it and to control who gets to use it after it becomes public.
We believe our patent strategy offers some protection against uses that may not be fully aligned with our mission to create access to innovative treatments for as many people as possible at an affordable cost to patients and healthcare systems.
Our focus: improving outcomes for the maximum number of people
Many people have asked us about our business model. Given that we are in the early stages of the development, the model is still evolving and will largely depend on the conditions of the regulatory approvals. In general, US law focuses on private companies maximizing value for shareholders only. UK corporate law is different: it requires us to create value for both shareholders and stakeholders. As a UK-based company, every COMPASS Pathways Board meeting starts with a reminder of this commitment.
Businesses might have different strategies to create value for shareholders. Charging high prices and stifling competition is one of them, but it is not the approach we plan to take. Instead, our goal is to provide broad access to all in need regardless of their ability to pay, creating greater value for health systems and translating to lower health insurance premiums and decreased healthcare cost. This is the approach our shareholders invested in and continue to support.
The high cost of clinical trials and drug development aside, the cost of manufacturing GMP psilocybin itself post-regulatory approval is likely to be relatively low. The future cost of Psilocybin Therapy will be determined at the point of care delivery by the treatment models, the services provided by the treatment centers, but mainly by the fees of individual providers. The creation of reimbursable models of care then becomes essential if we are to ensure that everyone who would benefit from Psilocybin Therapy can access it regardless of their ability to pay. It might be that “a thousand flowers will bloom” – and eventually the best models will prevail simply through quality and price competition, or that treatments will be rolled out in a more regulated way. This will require constant feedback and frequent course correction, as we continue to learn from our collective experience.
One way to decrease this uncertainty and ensure the accessibility of the treatment is by engaging in frequent in-depth conversations with the regulators and payers early in the process, just as we suggested after our first Heffter Board meeting in 2014. This remains our main strategy today.
To date, we have had conversations with regulators in many different countries in Europe and North America. We have assembled hundreds of pages of detailed feedback on the clinical development of psilocybin for depression and other indications, and on regulators’ general views of the challenges and opportunities for the clinical development of psilocybin. We share these insights regularly with MAPS. We also offered to share our plans and experience with Usona and Heffter. However, we understand that the psychedelic community is facing many challenges as it grows and some might not consider these perspectives a priority at this time.
We realize now that we could have taken more time to communicate with researchers who supported us during our early non-profit stage. At that time, we simply assumed that we were all motivated by the urgent need to create safe, effective, and sustainable options for patients. In our drive to get things done, we may have unintentionally hurt some people by not communicating clearly enough about our intentions and decision process that led us to move from non-profit to profit and from a focus on existential distress in cancer patients to treatment-resistant depression. We sincerely regret this and intend to do a better job in the future. Today, many researchers have continued working with us, while others have chosen not to, citing their discomfort with a for-profit approach. We respect their choice.
We also appreciate that not everyone agrees with our model. We believe different models of care and organizational structure can co-exist, and we embrace healthy competition through creating alternative solutions. We also understand that in the diverse psychedelic community, there is a range of views on how to move forward. We appreciate the dedication, skills, and achievements of those who have chosen to work on legalization efforts, and we do not think our models are contradictory. In fact, arguments for decriminalization can be enhanced by the evidence generated in large-scale clinical trials conducted according to the highest regulatory standards. Regardless of the results of the trials, the individual patient experiences and extensive safety data collected and published in the process can be of significant value in helping change public and legislative opinions.
The “elders” of psychedelic research have triumphed at what they set out to do. The world is paying attention, patients and clinicians are hopeful, leading research institutions are hosting conferences and developing research ideas, and institutional and private funders are willing and able to support further development. Scientists and clinicians now have a real chance to offer hope and help for millions of people suffering from psychological distress, regardless of their spiritual practices or ideological convictions.
The field of psychedelic research is entering a new chapter. This is both exciting and highly uncertain, as this work has never been done at scale and in full public view. Working in this historically sensitized and highly regulated space takes a wide range of skills, experience, sustainable funding, teamwork and collaborations across disciplines. With care and respect for differences of opinions, we know it is possible to have a constructive and thoughtful dialogue, and to collaborate in the interests of patients in need. We at COMPASS Pathways are committed to doing our part. We look forward to sharing lessons of successes and challenges with many of you in the future.
In the meantime, my son has recovered and now lives a happy and productive life. This was inconceivable just three years ago. Our story is not simply the story of a miracle cure, but the story of access to innovation, particularly for those who cannot afford it. We will have walked this challenging path so other families do not have to do so.
COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression
For online press release, see: https://www.prnewswire.com/news-releases/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression-834088100.html
COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its psilocybin therapy for treatment-resistant depression.
The FDA designates a drug as a breakthrough therapy if preliminary clinical evidence shows that it may demonstrate substantial improvement over available therapy. Breakthrough therapies are supported by the FDA throughout the clinical development programme to ensure as efficient a process as possible.
Breakthrough therapy designation is a significant milestone for psilocybin therapy and psilocybin research, and a testament to the work done over many years by research teams in the US, the UK and Switzerland. The Heffter Research Institute was the first to fund research in this field, and supported early studies at Johns Hopkins University, New York University, and Harbor-UCLA. In the UK, the Medical Research Council backed the proof-of-concept study of psilocybin for treatment-resistant depression at Imperial College London in 2015. COMPASS Pathways is now running the first large-scale psilocybin therapy clinical trial for treatment-resistant depression, which will take place in Europe and North America over the next year or so.
George Goldsmith, Executive Chairman, COMPASS Pathways, said, "This is great news for patients. We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression. The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible."
Treatment-resistant depression is a huge unmet need, affecting 100 million people around the world who do not respond to existing treatments. Depression is one of the fastest growing health problems we face today, and the leading cause of ill-health and disability worldwide. The breakthrough therapy designation for psilocybin therapy highlights the importance of supporting early research that can be translated to clinically meaningful outcomes.
Dr Robin Carhart-Harris, Head of the Psychedelic Research Group, Imperial College London, said, "In our 2015 study, we provided psilocybin to 19 patients in a clinical setting, coupled with psychological support, and found promising signals of efficacy and safety as treatment for treatment-resistant depression. The breakthrough therapy designation is a strong endorsement for the potential of psilocybin therapy. We look forward to learning more as further clinical studies are carried out, by our team at Imperial College as well as in COMPASS's multi-centre trial."
Dr David Nichols, Chairman of the Board, Heffter Research Institute, said, "Since its inception in 1993, Heffter has been helping to design, review, and fund the early phase clinical studies on psilocybin at research institutions in the US and Europe. We are delighted that psilocybin is being recognised as a breakthrough therapy and look forward to continuing our work with researchers and partners around the world so that we can alleviate the suffering caused by mental illness."
About COMPASS Pathways
COMPASS Pathways is a life sciences company, founded in 2016 to accelerate patient access to evidence-based innovation in mental health. We are developing psilocybin therapy through a late-stage clinical trial in Europe and North America for patients with treatment-resistant depression. We will improve mental health through the development of new patient care pathways, based on advances in neuroscience, psychotherapy, psychopharmacology, and technology. www.compasspathways.com
Tracy Cheung, firstname.lastname@example.org , +44-7966-309-024
COMPASS Pathways News | July 2018 Issue
This is the second of regular newsletters from COMPASS, highlighting recent and forthcoming events and developments that are relevant to us, our partners and healthcare system stakeholders.
It has been an incredibly busy time since the start of 2018. We are excited by the progress we have made across various areas, all of which promise benefits and hope for patients and their families. We have advanced our plans and preparations for our clinical trial on Psilocybin Therapy for treatment-resistant depression (TRD); and completed pre-clinical studies, which have provided compelling evidence on the safety of Psilocybin Therapy in animals and in-vitro models.
In addition, we have manufactured two batches of psilocybin, the equivalent of more than 20,000 doses of 25mg, to cGMP (Current Good Manufacturing Practice) standards to support regulatory assessments and our late-stage clinical trials; we are launching a Psilocybin Therapy study for healthy volunteers; and we have expanded our team and our board of directors.
About 100 million people suffer with TRD, and do not respond to existing treatments. In addition to the distress and suffering caused for individuals and their families, depression presents a severe cost burden for healthcare systems. Over the next few months, we will begin our TRD clinical trial in Europe and North America.
We’re building on the significant work that has already been done in this area, by gathering evidence in a larger population to see whether Psilocybin Therapy could provide a breakthrough to help patients suffering with TRD. If it does, we are committed to making sure as many patients as possible will benefit from the treatment.
In everything we do, we are guided by principles that put the patient first. They focus on delivering innovation and providing access to it, adhering to the highest standards of scientific rigour and integrity, and embracing openness and collaboration.
Our clinical trial on treatment-resistant depression
This trial will be a phase IIb dose-ranging study with 216 patients. The first patient will enter the trial in July or August in the UK. The trial will take place in 12 to 15 research sites across Europe and North America. If the trial is successful, it will be followed by phase III studies. Most likely these will compare the optimal dose to either placebo or standard of care.
Earlier this month, we held our first investigator and therapist training meeting at The Champalimaud Centre for the Unknown in Lisbon. This brought together more than 100 people from across Europe, who will be involved in managing the trial and working with patients. Over five days, the clinical teams reviewed the programme and protocol design, discussed recruitment and retention strategies, and received in-depth training to enable them to conduct the study to the highest levels of quality and consistency across research sites. Our clinical research partner, Worldwide Clinical Trials, was impressed by the unprecedented level of participation and commitment of the study teams. In his opening remarks, their president, Angelico Carta, described our partnership as “COMPASSion Worldwide”. We are excited to be working with Worldwide to bring this vision to life for patients.
Healthy volunteers study at Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
In July, we are launching a study of the “Effects of psilocybin on cognition and emotional processing” at the IoPPN, King’s College London, in partnership with the University of Zurich, Switzerland and Cambridge Cognition. Ninety healthy volunteers will be randomised to receive placebo, 10mg or 25mg of psilocybin, administered simultaneously in up to six participants. The study will explore the effects of psilocybin on cognitive and emotional empathy, executive function, memory, attention and cognitive flexibility. In addition to scientific insights, it will provide a unique opportunity for therapists involved in psilocybin research to support psilocybin sessions alongside some of the most experienced researchers and clinicians from the US, UK and Switzerland. The study will run for 16 weeks from 23rd July.
Manufacture of cGMP psilocybin
Through a great collaboration with our manufacturing and formulation partners, we have manufactured two 250g batches of psilocybin, the equivalent of 20,000 doses of 25mg, to the highest regulatory standards (cGMP – Current Good Manufacturing Practice). A large portion of this material is being used for stability testing to meet regulatory requirements. The remainder is now encapsulated, packaged and ready to be shipped to our trial sites. This will support our late-stage clinical trials in Europe and North America as well as independent investigator-led trials at leading academic sites on both continents.
Supporting independent psilocybin research
We are passionate about increasing access to treatments and options for patients, and furthering research that will improve mental health outcomes. So in addition to using our psilocybin for our own clinical trials, we are also making it available, free of charge, to members of the European College of Neuropsychopharmacology (ECNP) through its Medicines Chest programme. We are looking at extending this approach to other eligible scientific associations and researchers with approved protocols.
Psychedelic research in the news
There has been a real surge of interest in the potential of psychoactive medicines in recent months.
Two of COMPASS’s founders, George Goldsmith and Ekaterina Malievskaia, were guests on Rob Reid’s After On podcast and talked about their backgrounds and motivations, and the forthcoming treatment-resistant depression clinical trial.
Significant coverage has also been generated by a new book by Michael Pollan: “How to change your mind – what the new science of psychedelics teaches us about consciousness, dying, addiction, depression and transcendence.” COMPASS and our work is referenced in this book, as well as in an article Michael wrote for the New York Times Magazine in mid-May.
As a result, we are receiving numerous emails from patients and their families from all over the world. These messages inspire us to do all we can to develop and deliver accessible new treatment options for patients who are not helped by current medicines and therapies.
The importance of a sustainable business model
COMPASS is committed to accelerating patient access to evidence-based innovation in mental health. We want to develop and deliver medicines and therapies that can address significant unmet medical need (eg treatment-resistant depression) and then make sure they reach the patients who need them.
That is why we have decided to adopt a sustainable business model, in which we generate a reasonable profit to support and incentivise innovation. This strategy is already yielding important support for our research. For example, we have received our first R&D incentive payment from the UK government. As a private sector business, and based on our R&D investments, we will continue to receive these incentives which will enable us to fund more research. This virtuous cycle will encourage further private sector innovation in life sciences.
Drug development is a complex and costly process, particularly when it involves managing clinical trials and regulatory processes in multiple countries. We believe a balanced for-profit model, which aspires to deliver innovative therapies and enable patient access to them, is most likely to deliver the needed innovation on a long-term basis, which is critical to patients.
Our board of directors and scientific advisory board members
Our expanded board of directors has had its first meeting. Christian Angermayer, George Goldsmith and Ekaterina Malievskaia have been joined by three new independent directors. We welcome Annalisa Jenkins, who brings a tremendous amount of R&D expertise, having served as the Chief Medical Officer at Bristol Meyers Squibb and Head of R&D at Merck Serono; Thomas Lönngren who brings deep regulatory expertise, having led the European Medicines Agency for a decade; and David Norton who brings significant industry experience as former Company Group Chairman at Johnson & Johnson Pharmaceuticals and service on a number of boards.
We are also launching our scientific advisory board with leaders in neuroscience, psychiatry, regulatory science and health systems. They will be overseeing COMPASS's scientific research and clinical development programme to ensure we address the highest areas of unmet need with rigour and clinical equipoise. The members of the advisory board are:
Professor David Nutt MD PhD (Chairman)
- Edmond J Safra Chair in Neuropsychopharmacology, Imperial College London
- President, The European Brain Council
- Former President of the European College of Neuropsychopharmacology
Professor Dr Elisabeth Binder
- Director, Department of Translational Research of the Max Planck Institute of Psychiatry
- Associate Professor in the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine
- Member, Board of Directors of the European College of Neuropsychopharmacology
Professor Sir Alasdair Breckenridge CBE FRSE
- Former Chairman, UK Medicines & Healthcare products Regulatory Agency
- Chairman, Centre of Regulatory Excellence Advisory Board
Thomas Insel MD
- President & Co-Founder, Mindstrong Health
- Former Lead, Verily Mental Health team
- Former Director, US National Institute of Mental Health
Professor Zach Mainen PhD
- Director of Neuroscience Programme, Champalimaud Centre for the Unknown
- Leader of Systems Neuroscience Lab and founding director of International Neuroscience Doctoral Programme
Professor Luca Pani MD
- Executive Director of Global Medical Innovation, NeuroCog
- Former Director General, Italian Medicines Agency (AIFA)
Professor Diego Pizzagalli PhD
- Director, Center for Depression, Anxiety and Stress Research; McLean Imaging Center; Laboratory for Affective and Translational Neuroscience
- Professor in Department of Psychiatry, Harvard Medical School
Professor John Rush MD
- Professor Emeritus, University of Texas Southwestern MC & Duke-NUS Graduate Med School
- Recipient of Thomson Reuters: World’s Most Influential Scientific Minds (2014)
- American Psychiatric Association: Award for Research in Psychiatry (2007)
Professor Paul Summergrad MD
- Dr. Frances S Arkin Professor and Chairman of Psychiatry Department, Tufts University School of Medicine
- Past President, American Psychiatric Association
If you’d like to know more about what we are doing or have comments about COMPASS Pathways News, please get in touch with us at email@example.com. If you’d like to subscribe to our mailing list, you can do here any time.
COMPASS Pathways News | December 2017 Issue
END OF YEAR UPDATE
Dear friends, supporters and colleagues,
The holiday season is approaching, and as we begin dreaming of festive treats and spending the holidays cocooned in thick duvets with a cup of hot chocolate in hand, I would like to reflect on our journey this past year and share a few 2017 highlights.
Trial designed by multidisciplinary team
In February, we held our treatment-resistant depression (TRD) trial design meeting at London’s Home House, assembling experts and leaders from the fields of psychiatry, pharma development, neuroscience and psychedelics. Those of you who were there will remember the spirit of collaboration and mutual learning, and how energised we all were by the novelty and promise of the approach.
EMA scientific advice completed
Only a few months later we presented our trial design and clinical development programme to the European Medicines Agency (EMA), at a scientific advice meeting led by the head Italian regulator and psychiatrist, Professor Luca Pani. We were impressed by how deeply European regulators were thinking about our proposed approach, and how well informed they were about these old, yet new compounds. The EMA’s thoughtful feedback and questions, on topics ranging from pre-clinical data to post-regulatory approval scenarios, led us to revise our protocol and clinical development plan and to develop strategies that will ensure our trial demonstrates safety and efficacy.
Clinical trial programme started
Our clinical trial programme is led by Sue Stansfield, a former global executive at inVentiv Health. Early in her career, Sue completed her PhD focusing on serotonin, and one of her first research projects was conducted in collaboration with Prof David Nutt. We have a strong partner in Worldwide Clinical Trials, our contract research organisation. Worldwide was selected for its commitment to innovation and focus on Central Nervous System (CNS) research. In our first six months of working together, the Worldwide team have demonstrated exceptional engagement, flexibility and resourcefulness. Together we have completed regulatory and ethics submissions in five countries, and have received positive initial feedback from ethics committees and health ministries. We are particularly excited that we have had our first clinical trial approvals, from the UK’s Medicines and Healthcare Products Regulatory Authority and the Dutch Ministry of Health. Well done and thank you to everyone involved!
Trial sites selected
In June we began to look for potential trial sites. We were encouraged by the wealth of psilocybin research knowledge that exists in some of the oldest and most established academic institutions in Europe, and among many of the most reputable researchers and clinicians in the field of mood disorders. Twelve sites in the UK, Norway, Finland, the Netherlands, Germany, Portugal, Spain and the Czech Republic have now been selected. We are delighted that Professor Guy Goodwin, former head of Psychiatry at Oxford University and former president of the European College of Neuropsychopharmacology, has agreed to be a coordinating Principal Investigator of our trial. Our COMPASS/Worldwide team has visited all the sites - a definite highlight of the last six months. To all the Principal Investigators and their teams, thank you for your enthusiasm and determination to overcome any and all challenges!
Patient experience at the core of our trial
We have been developing innovative patient preparation and therapist training models, essential components that will help to ensure the safety and success of the study. With considerable input and guidance from Bill Richards, Torsten Passie, Peter Gasser, and the excellent team at MAPS (Multidisciplinary Association for Psychedelic Studies), we are finalising the structure of the therapist training process for the first group of European therapists. This will use a web-based training platform, followed by three days of in-person training, and an apprenticeship with experienced psilocybin therapists at three European academic sites. We are fortunate to be working with two technology partners who share our vision. Longboat specialises in digital support for clinical trials, optimizing the flow of information between patents and study teams, and improving patients’ experience of research participation. Longboat will be hosting our digital patient preparation platform, showing animations and videos about psilocybin. Another partner, Mindstrong, will be collecting behavioural markers of depressive symptoms via a mobile application, with the ultimate goal of personalised care for depression.
cGMP (Good Manufacturing Practices) psilocybin now available for research
This year, we have completed synthesis, formulation, stability testing, and all pre-clinical tests for psilocybin. Our psilocybin has made the transition from a research chemical to a medicinal product, ready to be approved upon successful completion of phase 2b/3 trials in the EU and US.
The availability of cGMP-grade psilocybin has stimulated a lot of interest in the scientific community. COMPASS will provide psilocybin for investigator-initiated studies in at least nine countries across Europe, North America and Australia for psychiatric and medical indications, as well as experimental studies, free of charge. All participating sites will be contributing to the unified safety database which will help expedite approval and, ultimately, patient access.
In addition to Sue Stansfeld, we have been joined by two new colleagues: John Boghossian, who is leading business and partnerships development, and Molly Lennard-Jones, our team coordinator. John graduated from MIT and the Harvard Business School and comes with experience in market access. Molly developed a strong interest in mental health after completing her research thesis on the role of personal narrative in PTSD among Holocaust survivors. Since September we have also been working with Chris Strutt and Tracy Cheung, formerly of GlaxoSmithKline and GE Healthcare respectively, who support us on public affairs and communications. We are fortunate to have such a talented and experienced group of people in the COMPASS team and our rate of progress has increased rapidly since they have been on board.
We have welcomed two new members to our advisory board: Dr Tom Insel, a neuroscientist and former head of the US National Institute of Mental Health; and Dr Paul Summergrad, the head of Psychiatry at Tufts University Medical School and former head of the American Psychiatric Association. We are deeply grateful to all of them and our ‘founding’ advisors - including Prof Sir Alasdair Breckenridge and Dr John Rush - for their continued support, expertise and wisdom.
Lastly, I want to express my thanks to two people without whom COMPASS would still have been a dream: Joe Heinen, our Chief Financial Officer, and Sarah Drummond, who makes all the important conversations and events happen.
It has been a very busy year and 2018 is set to continue in the same way. A few key events:
With all the positive signals following our regulatory submissions, we are well positioned to enrol our first patient in March 2018. We expect to complete the enrolment for the dose finding phase of the study by the end of 2018.
A study of 50+ healthy volunteers is planned for Q2 2018. This study will explore the safety and effects of psilocybin on cognitive function and emotional processing. It will also begin to collect safety data on the simultaneous administration of psilocybin in groups of 5-10 volunteers. The study will be supported by psychiatrists experienced in group administration of psychedelics as well as by our therapists-in-training. It will be an excellent opportunity to start building a platform for shared knowledge and professional development for mental health professionals interested in the emergent field of psychedelic research and therapy.
A Pre-Investigational New Drug meeting with the FDA (US Food and Drugs Administration) is planned for January 2018. We plan to share the results of the EMA Scientific Advice with FDA and seek approval for the replication of the confirmatory phase of our TRD trial in the US.
We are always on the lookout for talent. With scientific rigour and patient experience at the core of our work, we plan to hire a lead for therapy research and training, early next year.
We continue to be humbled and inspired by the task ahead of us. We are immensely grateful for the enthusiasm and expertise that has been so generously shared by everyone involved. Thank you for all of your support, it has made such a difference to our work and will undoubtedly make a difference in patients’ lives.
I wish you the happiest of festive seasons and all the best for the New Year.
Katya, on behalf of George, Lars and the COMPASS team
COMPASS Pathways News | December 2019 Issue
Reflections on a busy 2019 from Ekaterina Malievskaia, COMPASS Co-founder
Read our backgrounder to find out more about our company and the work we are doing
COMPASS Pathways and King’s College London announce results from psilocybin study in healthy volunteers
COMP360 (psilocybin) was well tolerated in healthy volunteers
‘A change is in the air’ – ISAD 2019 symposium
Hans Eriksson, our Chief Medical Officer, on our symposium entitled 'Psilocybin therapy for treatment-resistant depression … the road to the clinic."
COMPASS Pathways News | July 2019 Issue
Here are highlights of our activities in the first half of 2019 that we hope will move us closer to our goal of improving mental health care for as many as possible
COMPASS Pathways News | December 2018 Issue
As 2018 draws to a close, we reflect on another busy year and share our highlights of the last few months with you
Navigating mental health: COMPASS Pathways’ psilocybin research programme
Article written for the MAPS Bulletin Winter 2018, by Ekaterina Malievskaia, MD, MSc, Chief Medical Officer and Co-Founder of COMPASS Pathways
COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression
“This is great news for patients. The FDA will be working closely with us to expedite the development process” - George Goldsmith
COMPASS Pathways News | July 2018 Issue
This is a newsletter from COMPASS, highlighting recent and forthcoming events and developments that are relevant to us, our partners and healthcare system stakeholders
COMPASS Pathways News | December 2017 Issue
The holiday season is approaching, and as we begin dreaming of festive treats and spending the holidays cocooned in thick duvets with a cup of hot chocolate in hand, I would like to reflect on our journey this past year and share a few 2017 highlights