COMPASS Pathways: Our Mission, Progress and Future Perspectives

Kabir Nath

CEO, COMPASS Pathways

Part of our Year in Review series

As COMPASS Pathways embarks on its ambitious Phase 3 program, which will evaluate its COMP360 psilocybin therapy in patients with treatment-resistant depression, we invited CEO Kabir Nath to share a short perspective piece.

An urgent need

We’re currently living through a mental health crisis. Every 40 seconds, someone dies from suicide1. Depression affects 320 million people worldwide, but for one in three, existing treatments don’t work2. Care for people with treatment-resistant depression (TRD) is failing, and COMPASS Pathways is determined to change this.

TRD carries a huge burden. It has higher mortality rates, and associated medical costs are two to three times higher than non-TRD major depressive disorder (MDD)3. A recent survey in Europe by COMPASS Pathways showed that three of four people with TRD are unemployed and 60% had at least one mental health-related hospitalisation in the last 12 months4. People with TRD face higher prescription costs, more doctor visits and increased rates of hospitalisation5. Almost one in three people with TRD will attempt suicide at least once in their lifetime6.

Research in this field has fallen behind other areas of medicine and the current trial-and-error approach of treating depression takes time, often without success7. There is an urgent need for innovation in mental health and the development of effective treatment options.

COMPASS Pathways Treatment Room

Pioneering innovation

COMPASS is developing innovative therapies and combining them with psychological support and next-generation digital tools to forge new, sustainable mental health care pathways. COMP360 psilocybin therapy, our proprietary synthesised formulation of psilocybin, is currently undergoing phase 3 investigation in TRD, having already shown promising results in a phase 2b study that was the largest ever of its kind.

Unlike conventional antidepressant therapy that typically consists of daily oral administration, COMP360 psilocybin acts through a single-dose capsule, alongside psychological support from a trained therapist. If approved, COMP360 psilocybin therapy could offer a new approach to treating some of the most challenging mental health conditions, such as TRD. We are working closely with regulatory bodies and payors to ensure it can be integrated into healthcare systems and made accessible for the people who need it.  We are starting with TRD, and we are also studying COMP360 in two other areas of significant unmet need, anorexia nervosa and post-traumatic stress disorder.

See our Late-Stage Psychedelic Trials piece for more.

Building evidence

Like any new investigational drug, COMP360 psilocybin therapy must be tested rigorously to evaluate safety and efficacy for people with TRD. We have designed our clinical studies to ensure that they address the right questions for regulators, payors and insurers, so that COMP360 can be integrated into health systems, and supported by payors.

Our phase 3 pivotal programme will be our most robust and extensive to date. It is composed of two pivotal trials and long-term follow-up. Our first trial is designed to replicate our phase 2b study and will look at the effect of a single 25mg dose of COMP360 psilocybin, in combination with psychological support, compared with placebo. Our second trial will use three dose arms (25mg, 10mg and 1mg) and will investigate if a second dose can increase the number of responders and/or improve response. It will also explore the potential for a meaningful treatment response from repeat administration of COMP360 10mg. Our primary endpoint in both pivotal trials is the change from baseline in MADRS total score at week six.

If successful, we plan to use the data generated from these pivotal studies to apply for regulatory approval from FDA. We also plan to seek regulatory approval from health regulatory agencies around the world, including the EMA and MHRA. We expect top-line data from our first trial by the end of 2024 and our second trial by mid-2025.

Using the dataset from our phase 2b study, we are developing patient digital markers, to help stratify the population and predict outcomes. The anonymised patient-therapist conversations provide signals which may help identify those who will respond to treatment and may allow for the delivery of personalised, predictive and preventative care, and help determine patient outcomes after treatment.

Integrating into health systems

Psychological support and the next-generation digital tools we are developing are expected to help ensure COMP360 can be integrated into new, sustainable mental health care pathways. Psychological support is required for COMP360 psilocybin delivery, and the approach is non-directive, primarily to safeguard patient safety and prepare them for the psychedelic experience when taking COMP360 psilocybin. Patients need to feel safe during the experience, which is why we have worked with experts in psychology, psychiatry, and psychedelic therapy to design a training programme for therapists taking part in our clinical studies.

To enable more efficient and engaging delivery of COMP360 psilocybin therapy, we are creating digital tools and technologies for patients and healthcare professionals. Using the dataset from our phase 2b study, we are developing patient digital markers, to help stratify the population and predict outcomes. The anonymised patient-therapist conversations provide signals which may help identify those who will respond to treatment and may allow for the delivery of personalised, predictive and preventative care, and help determine patient outcomes after treatment.

In terms of treatment delivery, there is an existing and growing network of facilities in the US that we believe could deliver COMP360 psilocybin therapy, if approved. In this market, our primary COMP360 psilocybin delivery partners would be specialised interventional psychiatry treatment centres, which have the right infrastructure, capabilities / workforce and experience treating TRD patients.

Our mission

We are determined to build the future of mental health care for patients living with often invisible, yet profoundly debilitating conditions.  A clinical and cultural shift in mental health care is essential to help millions of individuals—and their friends and families—who are affected.

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Part of our Year in Review series

This content is part of our 2022 Year in Review, which looks back at the past year through commentary and analysis, interviews and guest contributions.

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  3. Li G, et al. Annals of General Psychiatry. 2019;18,23.
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  7. World Health Organization. Depression and other common mental disorders: global health estimates. Available at: https://apps.who.int/iris/handle/10665/254610. License: CC BY-NC-SA 3.0 IGO. Accessed January 2023.