Compass Pathways Launches UK Phase of Landmark Psilocybin Study for Treatment-Resistant Depression

NEW YORK- Compass Pathways plc (Nasdaq: CMPS), a biotechnology leader dedicated to advancing mental health treatments, has announced the initiation of the UK component of its phase 3 program investigating COMP360 psilocybin treatment for treatment-resistant depression (TRD). The announcement, made today, marks a significant step in the largest randomized, controlled, double-blind clinical program for psilocybin treatment to date, following promising outcomes from its phase 2b study.

The research, involving two pivotal trials named COMP 005 and COMP 006, is set to take place across multiple sites in the UK, including the newly inaugurated Centre for Mental Health Research and Innovation in London. The Centre, a collaboration between Compass, South London and Maudsley NHS Foundation Trust, and the Institute of Psychiatry, Psychology & Neuroscience at King’s College London, aims to accelerate psychedelic research and integrate new mental health treatment models in the UK.

COMP 006, an international trial including the UK, will explore three different dosages of COMP360 (25mg, 10mg, and 1mg), while COMP 005, based in the US, will examine the effects of a single 25mg dose compared with a placebo.

The Centre for Mental Health Research and Innovation, positioned at the Maudsley Hospital in South London, will be led by top clinical investigators, Professor Allan Young and Dr. James Rucker. The research will initially focus on pressing needs like TRD and anorexia nervosa, aiming to develop new care models and integrate potential future treatments into health systems. The Centre will also delve into digital technologies for personalized mental healthcare and therapist training.

Kabir Nath, CEO of Compass Pathways, emphasized the urgency of innovating in mental health treatment, highlighting the role of public-private partnerships in this endeavor. The launch of the phase 3 study in the UK represents a critical step in addressing unmet needs in mental health care. Nath also underlined the commitment to making these potential treatments accessible and equitable.

David Bradley, Chief Executive of South London and Maudsley NHS Foundation Trust, expressed enthusiasm for the partnership and the Centre’s role in developing innovative treatments to improve mental health care across the UK.

Professor Allan Young, Head of Academic Psychiatry at King’s College London, noted the milestone this represents in psychedelic research for mental health conditions. The phase 3 trials, building on previous studies, aim to evaluate the safety and effectiveness of psychedelics for various mental health conditions and assess their feasibility for widespread use.

Compass Pathways, with a focus on transforming mental health care, is pioneering a new model of psilocybin therapy. Their proprietary synthetic psilocybin formulation, COMP360, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and Innovative Licensing and Access Pathway designation in the UK for TRD. The ongoing phase 3 program is a monumental step in their quest to offer new, effective treatments for mental health challenges.