It’s important that companies seek input from the beginning so that products and services are designed with an understanding of individual wellness goals. This is what we’re doing with COMPASS.
2020 was a momentous year, in which fundamental assumptions of how we live and work were challenged on a global scale. We also saw an unprecedented appreciation of the role that science, medicines and vaccines play in improving public health. And a greater understanding of how medicine and vaccine developers can work closely with regulators to get products clinically tested and approved in record times. While many of us long for the way things were before the pandemic, I hope some of these systemic changes in how we bring innovation to patients are here to stay.
Attention has been rightly focused on physical health aspects of COVID-19. However, many people are now also recognising the burden on mental health, arising from the fear, stress, economic uncertainty and social isolation that we have experienced in the last year. The pandemic has had an impact on us all, not least on those who have been directly affected by the disease including patients, families and frontline workers. The effects are likely to be felt for months and years after we learn how to live alongside COVID.
Even before the pandemic, mental health care was in crisis. At COMPASS we talk about the fact that “everyone has a story”, whether that’s about themselves or a family member, friend or colleague. Mental health care today works for some but is not good enough for far too many people. Our company has a strong sense of purpose – we are committed to bringing evidence-based innovation to more people and to finding ways to help all those who are suffering.
Mental health care today works for some but is not good enough for far too many people.
As a team, we have been fortunate to be able to carry on with our work throughout the last year, seeing each other every day, albeit on a screen, and continuing to collaborate with people around the world in clinical trial sites, research institutions and other organisations. Our team spirit has shone through organised events such as the COMPASS Summer and Winter Games (in compensation for the postponed Olympics), comedy nights and quizzes, and a fundraising campaign for a group of London homeless charities. More than a third of the company has joined since we’ve been working remotely but apart from not knowing everyone’s height, we are getting to know each other quickly, perhaps helped by the gallery window into everyone’s home.
Importantly, we have been making continued progress on our phase IIb clinical trial of COMP360 psilocybin therapy in treatment-resistant depression (TRD), now in 22 sites in 10 countries, with data expected at the end of the year. We have been extremely impressed by the creativity and commitment of everyone involved in minimising the disruption from COVID across all our trial sites.
Our first clinical trial is in TRD because of the huge unmet need in this area and the significant impact of this illness on people’s lives. We have also been expanding our COMP360 psilocybin therapy programme into other areas of need, through signal generating investigator-initiated studies which are exploring indications including anorexia, body dysmorphic disorder, bipolar type II disorder, and major depressive disorder in cancer patients. If promising signals are found in these studies, we will consider moving them into phase II development programmes.
We also have an active preclinical programme, which completed over 20 new studies in 2020. In addition, our newly expanded Discovery Center is exploring optimised psychedelic compounds. We envision some of these projects progressing to clinical development programmes over the next few years, again focused in areas of unmet medical need.
Our work in psilocybin therapy takes an integrative approach, with the combination of medicine, psychological support and digital technologies.
Our work in psilocybin therapy takes an integrative approach, with the combination of medicine, psychological support and digital technologies. We have steadily added capability in our therapist training area so we can train and support the therapists required for our phase III programme. Ultimately, we aim to create a precise, predictive and preventative model of care for patients who are not served by the current system. With your support, we have now raised over $250 million since our initial financing in the summer of 2017. This is enabling us in our mission to accelerate patient access to evidence-based innovation.
Transforming the patient experience in mental health care means that we must work closely with leaders in clinical care. In addition to working with academic centres on investigator-initiated studies, we have established the first in a planned network of Centres of Excellence, where we can research and prototype the delivery of this new model of care in psychiatry. All of this must be grounded in a deep understanding of the needs and interests of patients. We have been privileged to work with the Depression and Bipolar Support Alliance (DBSA), listening to and learning from their groups of patients, or peers, as they are called. Our commitment to broad patient access inspired our support for the Grady Trauma Project in Atlanta, a research study into mental health care needs and attitudes to psychedelic therapy, in marginalised communities.
All of this must be grounded in a deep understanding of the needs and interests of patients.
We are a mental health care company, but our first work is in developing psilocybin therapy, because that’s where we see the greatest promise for patients. Others agree and several moves towards psilocybin legalisation and access have recently taken place in the US and Canada. In Oregon, for example, a measure was passed to develop legal ways of providing access to psilocybin therapy. We have always been clear that the regulatory route – rather than the legislative route – is the best way to assure patients of the safety, efficacy and quality of any medicine. This route is also the most likely way to have a therapy be reimbursed, making it accessible to more people.
Over the last year we have been inspired by so many people – health workers, scientists, vaccine developers, patients, our own families and friends. I have been inspired by our COMPASS team who bring our values – compassionate, bold, rigorous, inclusive – to life every day. I’d like to thank them for everything they do. This report reflects their work and their dedication to patients and a world of mental wellbeing.
We are all grateful for the support of our investors who make this work possible.
Warm regards,
Lockdowns haven’t held us back in the last year. We took big steps forward in fundraising, strengthening our team, executing our clinical trial programme, progressing patient access strategies, and beginning to develop new compounds, indications and technologies. Here are some highlights.
Jason is Managing Director and Chief Medical Officer at Thiel Capital
Piers was previously CFO of Verona Pharma plc
$80 million raised in process led by Lars Wilde, our President and Chief Business Officer
Robert is EVP and Chief Strategic Officer at Otsuka
Trevor was previously SVP of Global Safety and Regulatory Sciences at Biogen
We added a German utility model (March 2020) and two UK patents (May and July 2020) to our first US patent (Dec 2019)
This study at Emory University (Atlanta, USA) is exploring mental health care needs and attitudes towards psychedelic therapy in underprivileged communities
We are working with University of the Sciences (Philadelphia, USA) to develop new optimised psychedelic compounds targeting the 5-HT2A receptor
Linda is Chairman and CEO of Financial Health Associates International
Aquilino Cancer Center (Rockville, USA) launched a clinical trial of psilocybin for depression in cancer, in a newly designed Cancer Center. COMPASS provided support, training and funding for the study, as well as input into the Center design
$146.6 million raised in an upsized initial public offering
The Psychiatry Consortium is an international collaboration to accelerate drug discovery and development in areas of urgent, unmet medical need
Sheppard Pratt (Baltimore, USA) is our first Centre of Excellence and will model the “clinic of the future”, working as a research facility and innovation lab
Our phase IIb trial of psilocybin therapy for treatment-resistant depression is expected to report data in late 2021. We added our 22nd site to the trial in January 2021
We have created a network of world-leading scientists from across the US, working together from their own labs, in an expansion of our Discovery Center
Our mission is to accelerate patient access to evidence-based innovation in mental health. We focus our efforts on those who are not helped by current treatments. Our first priority is to bring COMP360 psilocybin therapy to some of the millions of people who suffer with treatment-resistant depression (TRD).
We are pioneering the development of this therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. The US Food and Drug Administration (FDA) has designated COMP360 a Breakthrough Therapy for TRD, and we are conducting a phase IIb clinical trial in 22 sites across Europe and North America.
We are also exploring other areas of unmet need in mental health, beyond TRD. We want to reduce the underlying stigma associated with mental health. By understanding that “everyone has a story” and putting the patient at the heart of what we do, we can transform mental health care and the patient experience of it.
We live by our values of being compassionate, bold, rigorous and inclusive. Many of us at COMPASS have been personally touched by mental health challenges and know that existing care options are not good enough. We are determined to reduce the personal and economic burden of mental health suffering, as we take strides towards our vision of a world of mental wellbeing.
“We like to say we think differently about mental health. We would like to show that we act differently as well.”
Ekaterina Malievskaia, Chief Innovation Officer, COMPASS Pathways
Read our charters
“We like to say we think differently about mental health. We would like to show that we act differently as well.”
Ekaterina Malievskaia, Chief Innovation Officer, COMPASS Pathways
Read our charters
Our primary focus remains on psilocybin therapy for treatment-resistant depression (TRD), the convergence of a highly promising medicine with an area of huge unmet medical need.
Alongside psilocybin therapy for TRD, we are beginning to build a pipeline of new indications, new compounds and new technologies. In this effort we are fortunate to be collaborating with knowledgeable partners who share our values and our goals. We are working together to improve patient experience and patient outcomes, through access to evidence-based innovation.
Here are a few of our partners and some of the things we’re working on.
Lars Wilde, President and Chief Business Officer, COMPASS Pathways
Depression and Bipolar Support Alliance (DBSA)
“It’s important that companies seek input
from the beginning”
Sheppard Pratt
Centre of Excellence
“There’s an amazing synergy between
Sheppard Pratt and COMPASS”
Aquilino Cancer Center and Bill Richards Center for Healing
“Cancer care is not just about treating cancer with chemotherapy, surgery and radiotherapy, but really whole person healing”
Exploring new indications with COMP360
“COMP360 psilocybin is being used in studies exploring a wide range of indications”
COMPASS Discovery Center
“I’m really excited to be part of a team of world-leading scientists ”
Digital health
“Digital technologies have the potential to enhance and improve every part of the psilocybin therapy process”
It’s important that companies seek input from the beginning so that products and services are designed with an understanding of individual wellness goals. This is what we’re doing with COMPASS.
Phyllis Foxworth, DBSA
COMPASS is working with the DBSA to better understand lived experiences of people with depression, so that our actions are informed by patient needs. The DBSA is the leading peer-focused organisation in the US for people living with mood disorders, providing education, tools and peer support services.
We are determined that all our innovations in mental health care are founded upon patient input. Our work with advocacy groups like the DBSA provides valuable insights into the needs of patients and their caregivers across a wide variety of experiences, demographics, and geographies.
There’s an amazing synergy between Sheppard Pratt and COMPASS. Sheppard Pratt treats over 70,000 patients each year with a diverse range of mental health conditions. Our partnership enables us to better understand the potential of psilocybin therapy in a number of those different conditions.
Scott Aaronson MD, Sheppard Pratt Institute for Advanced Diagnostics and Therapeutics
In January 2021, we announced our first Centre of Excellence in collaboration with The Sheppard Pratt Institute for Advanced Diagnostics and Therapeutics (Baltimore, USA).
The Centre of Excellence at Sheppard Pratt is led by Scott Aaronson MD, Director of Clinical Research for both. The Centre will model the “clinic of the future”, showcasing the best thinking in science, therapy, technology, and design. Working as a research facility and innovation lab, it will generate evidence to shape therapy models in mental health care, train and certify therapists, conduct clinical trials including proof-of-concept studies, and prototype digital solutions to improve patient experience. Dr Aaronson is already using COMP360 in two investigator-initiated studies in psilocybin therapy for severe treatment-resistant depression and bipolar type II depression.
Cancer care is not just about treating cancer with chemotherapy, surgery and radiotherapy, but really whole person healing. In collaboration with COMPASS, we recently opened the Bill Richards Center for Healing which is focused on emotional support and wellbeing for patients and their families.
Dr Manish Agrawal, Aquilino Cancer Center
The Aquilino Cancer Center is a specialist cancer center in Rockville, Maryland, USA. COMPASS was part of the team that developed the Bill Richards Center for Healing which opened in September 2020, and provided support, training and funding for an investigator-initiated study using COMP360 psilocybin therapy in cancer patients with depression.
We believe that this is the only study of its kind taking place in a cancer centre and is different from previous psilocybin therapy studies in cancer patients in two ways. First, it involves simultaneous administration, with one-to-one support, as well as group preparation and group integration. And second, the study cohort have a range of different cancers and are at different stages of the cancer journey.
COMP360 psilocybin is being used in studies exploring a wide range of indications, from depression and bipolar disorder to anorexia and chronic cluster headache.
Trevor Mill, Chief Development Officer, COMPASS Pathways
Our synthetic psilocybin, COMP360, is being used in a number of exploratory, signal-generating studies, looking at areas of unmet need in mental health care. We do not sponsor these investigator-initiated studies (IISs), many of which use their own protocols and study designs, but we will assess the data they generate, and consider moving any promising indications into further development.
The indications being explored in these studies include anorexia, autism, bipolar type II disorder, body dysmorphic disorder, chronic cluster headache, depression in cancer, MDD, severe TRD, and suicidal ideation.
The work is being carried out in institutions around the world, including Imperial College London, Kings College London, Maryland Oncology Hematology (Aquilino Cancer Center), New York State Psychiatric Institute at Columbia University Medical Center, Sheppard Pratt, UC San Diego School of Medicine, University of Copenhagen, and University of Zurich.
I’m really excited to be part of a team of world-leading scientists looking for the next generation of compounds that could make a difference to patients.
Dr Jason Wallach, University of the Sciences
Our Discovery Center was established in August 2020 under a sponsored research agreement with University of the Sciences (USciences) in Philadelphia. It brings together world-leading scientists and their teams, working from their own labs in a virtual network, to develop new optimised psychedelic compounds to address unmet medical needs. COMPASS will be the exclusive licensee for all new compounds generated.
Dr Jason Wallach, Assistant Professor of Pharmaceutical Sciences at USciences, is leading the work with the COMPASS team, alongside Dr Adam Halberstadt, Associate Professor, Psychiatry, UC San Diego, School of Medicine, and Dr John D McCorvy, Assistant Professor, Department of Cell Biology, Neurobiology and Anatomy, Medical College of Wisconsin.
Novel digital technologies combined with machine learning have the potential to enhance and improve every part of the psilocybin therapy process. We want patients to be partners and to participate fully in discussions about how we use data responsibly.
Greg Ryslik PhD, SVP, Data Science, Machine Learning and Digital Health Research, COMPASS Pathways
Our rapidly growing digital team is researching and developing technology applications to improve the safety, efficacy and accessibility of our psilocybin therapy. We believe these technologies will enable us to deliver therapy at scale, and to provide personalised care pathways in mental health that could help predict and prevent deterioration and relapse.
We are constantly working to enhance our existing patient preparation and therapist training platforms. We are now also developing therapist feedback and monitoring tools assisted by AI (artificial or augmented intelligence). In our phase IIb clinical trial, we are collecting digital phenotyping information from patients through the measurement of human-smartphone interactions. After the trial, these data will be analysed and integrated with information from validated psychiatric scales to develop AI-based algorithms that provide insights into relapse as well as recovery.