COMPASS was created in 2016 by our co-founders who experienced first-hand just how difficult it can be to find adequate mental health care for a loved one. Six years later, our goal remains the same: to reduce mental health suffering, at scale, through evidence-based approaches.
We are working on a number of mental health illnesses, but our first focus has been on treatment-resistant depression (TRD) because more than 100 million people around the world suffer with TRD. The burden on patients and their families is enormous, but the stigma around mental health challenges means that their stories often go unspoken and unheard.
Thank you to Trish, Dee, and Eric for speaking out about what it’s like to live with TRD.
Dear friends of COMPASS Pathways,
We started COMPASS because we wanted to transform the lives of those suffering with serious mental illness. In 2021, we made significant progress toward this goal.
We are working at a relentless pace, driven by the significant and growing unmet need in mental health care. As Covid recedes from being a global pandemic, the toll on mental health will become even more apparent. There are far too many patients today who have not been helped by existing treatments and who need new options. Our team and research partners are fully committed to developing new therapies to reduce this suffering, at scale. We are also working closely with regulators, payers and health systems, early in the process, to ensure far-reaching and generational impact by making any approved therapy reimbursed and accessible to all who might benefit.
"Our mission remains the same: to accelerate patient access to evidence-based innovation in mental health. 2021 has seen us establish a strong leadership position in our area of science and psychedelic therapy."
2021 key accomplishments
The highlight of the year was the positive results from our COMP360 psilocybin therapy phase IIb trial in patients suffering with treatment-resistant depression, or TRD. This randomised, controlled, double-blind trial is the largest psilocybin therapy study ever completed. It demonstrated rapid and sustained response for patients receiving a single 25mg dose of COMP360 psilocybin with psychological support. The trial has provided COMPASS with a wealth of data and evidence to support our moving forward into phase III studies, often the final step before submitting a new drug application with the FDA. We are also developing the evidence required by payers to ensure reimbursed access. Regulatory approval must go hand-in-hand with reimbursement so patients can benefit regardless of their ability to pay. Plans for these studies will be finalised over the next few months, following discussion with regulators as part of our ongoing dialogue with them.
We also made important progress in a number of other areas of our business:
We are expecting another year of great progress, with milestones to include:
Moving into the next phase
As we prepare to move our COMP360 psilocybin therapy into phase III development, COMPASS itself moves into the next phase, with a rapidly growing team of talented and committed people, a strong operational and financial base, and the support of many excellent partners. We continue our work with a keen focus on our values of being compassionate, bold, rigorous and inclusive, and take seriously our responsibility for bringing effective therapies to patients as quickly and safely as possible.
"I am grateful to each member of our COMPASS team as well as our investors and partners, for your commitment to and support for our mission."
We are all especially grateful to the patients on our trials who have contributed to deepening our understanding of how to help them and countless others as we seek to create a world of mental wellbeing.
With deep appreciation,
Chairman, CEO and Co-founder
In 2021 we made history with the completion of the world’s largest psilocybin therapy clinical trial. This was one of many highlights in a year in which we took a giant leap forward in our work to transform mental health care.
Our groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for TRD* showed rapid and sustained response for patients receiving a single 25mg dose. We saw similarly positive data from our exploratory phase II study of COMP360 COMP360 psilocybin therapy alongside antidepressants
We launched a phase II study to explore the effectiveness of COMP360 psilocybin therapy in PTSD*
Investigator-led studies at Imperial College London (UK) and Aquilino Cancer Center, Maryland (US) showed positive results for COMP360 psilocybin in major depressive disorder
We are developing new psychedelic compounds at our expanded Discovery Center and through a partnership with Dr Matthias Grill of MiHKAL GmbH
Our work and research using COMP360 has been published in a number of publications this year including Frontiers in Psychiatry; The New England Journal of Medicine; and Journal of Psychopharmacology. We also published a White Paper on the TRD crisis in the United States
*TRD = treatment-resistant depression, *PTSD = post-traumatic stress disorder
In 2021, we completed the world’s largest psilocybin trial – a randomised, controlled, double-blind phase IIb study of COMP360 psilocybin, given in conjunction with psychological support from specially trained therapists, to 233 patients.
The topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. Patients also showed improvements in other areas including quality of life measures.
*TRD = treatment-resistant depression
We have launched a phase II study into our second clinical indication, PTSD, another area of high unmet need.
This multi-centre, fixed-dose open-label study will enrol 20 participants to evaluate the safety and tolerability of COMP360 psilocybin therapy in people who suffer with PTSD resulting from trauma experienced as adults. The study will begin at The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London.
*PTSD = post-traumatic stress disorder
In addition to the preclinical work at our Discovery Center in the US, we are partnering with Dr Matthias Grill of MiHKAL GmbH in Switzerland on a research project to develop new product candidates. The substances being explored include a variety of psychedelic and empathogenic compounds, some of which are prodrugs – pharmacologically inactive compounds which are metabolised inside the body to produce an active drug.
We have made good progress with screening and developing new compounds through our expanding preclinical programme, and plan to move some of these into clinical development within the next two years.
We are delighted to be a Founding Supporter of the British Neuroscience Association (BNA)’s inaugural Scholars programme, set up to support students from under-represented ethnic groups to thrive in neuroscience, and build a supportive community through networking opportunities, bursaries and mentorship. This sponsorship is part of our ongoing commitment to equity, diversity and inclusion (EDI) in our industry and our workplace.
We are deeply grateful to all the patients involved in our clinical trials and the therapists who support them – our company exists to transform mental health care, and we couldn’t do it without them.
Last year, we developed our charters: our commitments to how we will work with patients and therapists, developed with their input and reflecting their needs. Our charters are one way in which we hold ourselves accountable to working in a responsible and ethical way, with the people whose lives are being impacted by our clinical trials.
One year later, we’ve reflected on the ways in which we’ve made progress towards meeting these commitments, and the work that there is still to do. Our whole team is focused on doing more, every day, as we move closer to achieving our goal of accelerating patient access to evidence-based innovation in mental health.
Ekaterina Malievskaia MD, Chief Innovation Officer and Co-founder
We will report on our progress towards achieving these commitments annually, and update them to reflect patient needs, as we work to bring psilocybin therapy to everyone who might benefit from it.
We will report on our progress towards achieving these commitments annually, and update them to reflect therapist needs, as we work to bring psilocybin therapy to everyone who might benefit from it.
Diversity & inclusion