Transformative therapies

Investigational COMP360 psilocybin therapy is our first treatment in development; it combines COMP360 psilocybin (our synthetic, high-purity, polymorphic crystalline formulation of psilocybin, a psychoactive compound) with psychological support and digital tools. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA) for treatment-resistant depression (TRD). Learn more about our COMP360 psilocybin therapy here.

We are running clinical trials of COMP360 psilocybin therapy for three indications of high unmet medical need:

Treatment-resistant depression (TRD)

100 million people are not helped by existing therapies and suffer with TRD¹. As many as 30% of these attempt suicide at least once during their lifetime. ^2,3

Phase 3

We have begun our Phase 3 pivotal programme for COMP360 psilocybin in TRD, which includes 2 pivotal trials. Our programme is the first ever Phase 3 programme of psilocybin therapy globally.

Phase 2b

In late 2021, we completed a phase 2b study for psilocybin therapy. This was the world’s largest psilocybin therapy clinical trial, with 233 participants in 22 sites across Europe and North America. In November 2022, The New England Journal of Medicine (NEJM), the world’s leading peer-reviewed medical journal, published the positive results from its phase 2b trial of COMP360 psilocybin therapy for TRD.

Post-traumatic stress disorder (PTSD) – phase 2 ongoing

Over 300 million people will experience PTSD at some point in their lives⁴, yet only 20-30% of patients treated with currently approved interventions will make a full recovery. The phase 2 study will include 20 participants, and is taking place at The Institute of Psychiatry, Psychology & Neuroscience at King’s College London, and Icahn School of Medicine at Mount Sinai. Learn more here.

Anorexia nervosa – phase 2 ongoing

Anorexia nervosa carries the highest mortality rate of all psychiatric disorders⁵ and there is no approved pharmacological treatment option for those living with the condition. The study will recruit 60 participants and currently has four trial sites in the US and UK. Learn more here.

We have created one, integrated digital platform to optimise the care model we use in our clinical trials. It includes three digital tools:

MyPathfinder app, provides guidance to clinical trials participants throughout COMP360 psilocybin therapy. The app is designed to help participants navigate the therapy programme by providing timely educational content about COMP360 psilocybin. The app also collects clinically relevant behavioural data and biomarkers for research analysis. Patients have complete control over what data is collected from their device, on a per-study, per data-type basis. View demo here.

Therapist COMPanion, a web-based portal that assists therapists through their training, and through all phases of our clinical trials. It provides a standardised approach to therapist training and performance evaluation. We are developing AI to automatically transcribe and translate therapy sessions for fidelity and training purposes, and to ensure our care model is delivered consistently and according to our quality standards.

Chanterelle, our AI and analytics infrastructure that supports the continuous improvement of our care model and training programme using the data collected through myPathfinder and Therapist COMPanion. We aim to generate novel insights into the predictors and drivers of therapeutic outcomes, the patient experience, and therapist performance to ultimately provide a personalised, predictive, and preventative approach to patient care. In the future, this may lead to better outcomes for patients and lower costs for health systems. Read more in our paper.

Clinical trials transparency

We publish the results from our key clinical trials and provide non-technical lay summaries of publications and their relevance. Click on the links to access the results of our completed trials: healthy volunteers study (89 participants), phase IIb results for TRD (233 participants), and SSRI antidepressants in TRD (19 participants). We also support the publication of results from independent studies that use COMP360.

Investigator-Initiated Studies (ISS) Programme

Through our Investigator-Initiated Studies (ISS) programme, we may provide COMP360 psilocybin to researchers free of charge, in exchange for the right to add the safety data generated during these studies to the database we will submit to regulators for the approval of COMP360 psilocybin therapy. As a result, 13 investigator-initiated studies have been launched, 5 of which have been completed. These studies may provide signals for new potential indications for COMP360 psilocybin that we can explore further and bring into our development pipeline.

COMP360 is our formulation of psilocybin, an active ingredient in some species of mushrooms, often referred to as ‘magic mushrooms’. COMP360 is produced through a synthetic process, according to current Good Manufacturing Practices, an international standard for manufacturing. This allows us to control the compounds’ purity and consistent quality.

As part of our engagement with regulators, such as the FDA and EMA, we rigorously assess the safety data associated with all administrations of COMP360, whether in our own sponsored-trials, or in investigator-initiated studies.

In our clinical trials, COMP360 psilocybin is administered in conjunction with psychological support from therapists. This is key to ensure participants feel well prepared for, and supported during, the 6-8 hours administration of COMP360 psilocybin. The therapists also support the participants to reflect on their experience during the administration session and to define actions to create new emotional and behavioural patterns. Recruiting the right professionals and training them appropriately for the therapist role is therefore a key part of safeguarding our patients.

The therapists working in our clinical trials are selected according to strict educational and professional criteria. They must be trained mental health practitioners, with relevant clinical experience. We have a robust training programme therapists must complete, including rigorous didactic and clinical training, prior to engaging with patients. In addition to training, each therapist receives mentorship and continuing education throughout the duration of our clinical trials. Learn more about our programme in our paper published in Frontiers of Psychiatry. Read interviews with therapist trainers here and here.

The protocols for our sponsored clinical trials are developed with and approved by regulators and informed by advisory boards. They are conducted according to Good Clinical Practice. Throughout our trials, patient safety is monitored by trial investigators, physician medical monitors, as well as an independent Data and Safety Monitoring Board. To ensure patient safeguarding, all preparatory, administration and integration sessions are recorded. This enables us to monitor the therapists’ performance and fidelity to our method, and to use these learnings to continuously improve our training programme.

Depression and Bipolar Support Alliance (DBSA)

We have worked with the DBSA to learn more about the experiences of people living with depression. We have hosted 10 workshops, with approximately 60 patients. We covered topics such as treatment goals and unmet needs, digital mental health tools, and comorbidities. We learned that people are willing to contribute to the development of new treatments but often don’t know how, other than through participating in clinical trials. This finding reinforces the importance of COMPASS creating opportunities for patients to share their experiences to inform our R&D efforts. Hear from DBSA participants what it’s like to live with TRD here.

We also sponsor other DBSA projects, such as the Transform the Definition of Wellness campaign. Read more about our work with DBSA here.

GAMIAN-Europe

We have partnered with the Global Alliance of Mental Illness Advocacy Networks-Europe (GAMIAN-Europe), a patient-driven organisation, that represents and advocates for individuals experiencing mental health challenges. We ran a workshop with GAMIAN-Europe to understand the treatment experiences of European patients and get feedback on tools used in clinical trials. We also supported GAMIAN-Europe’s Quality of Life project, aimed at raising awareness of the perspectives of patients and methods to improve their quality of life. This resulted in a patient guide, which contains tips for achieving a good quality of life with a mental health condition. Read more here.

In March 2022, we launched the Mental Health Experiences community, a private online group formed of 100 people with personal experience of TRD. The community is made up of people from several North American and European countries and a diverse range of backgrounds, including 42% ethnic minorities and 30% LBGTQ+. The community discusses different themes, such as the experience of living with depression and clinician relationship. Listening to people’s lived experiences helps us understand the unmet needs of patients and to focus on these needs as we work to develop new treatments.

We support Sound Mind, an organisation working to build a community and culture that breaks the stigma surrounding mental health by reaching younger generations through music. We supported their 2021 Musical Festival in Central Park.