- UK sites to participate in part of pivotal phase 3 program following Medicines and Healthcare Regulatory Agency approval of study
- Research will take place in the UK, including at the newly opened Centre for Mental Health Research and Innovation in London, developed in partnership with South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology & Neuroscience at King’s College London
Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the initiation of the UK component of its phase 3 program of investigational COMP360 psilocybin treatment in treatment-resistant depression (TRD). The research will take place in multiple sites in the UK, including at the Centre for Mental Health Research and Innovation (“the Centre”) in London, which officially opened today.
The ongoing phase 3 program is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted and follows promising results from Compass’s phase 2b study of COMP360 psilocybin treatment. The phase 3 program consists of two pivotal trials (COMP 005 and COMP 006), and each trial has an integrated, long-term outcomes component.
COMP 006 will take place in the UK and globally and will study three dose arms of COMP360 (25mg, 10mg and 1mg). COMP 005 is a US-based trial examining the effect of a single 25mg dose of COMP360 psilocybin, compared with placebo.
Research at the new Centre for Mental Health Research and Innovation
The COMP 006 trial will be conducted at research sites across the UK, including at the new Centre for Mental Health Research and Innovation, which officially opened today.
The Centre was established to accelerate psychedelic research and develop new models of care for mental health in the UK, as part of a pioneering long-term strategic partnership between Compass, South London and Maudsley NHS Foundation Trust, and the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London.
Located at the Maudsley Hospital in South London, the dedicated and purpose-built space will be run by leading clinical investigators, Professor Allan Young, Head of Academic Psychiatry at King’s College London, and Dr James Rucker, Consultant Psychiatrist and Lead of the Psychoactive Trials Group at King’s College London. Research will initially focus on areas of urgent need, including TRD and anorexia nervosa.
The Centre will assist in the development of new models of care to help integrate these investigational treatments into health systems, if approved in the future. This will include evaluating real-world evidence, researching and developing digital technologies that may help to deliver personalized, predictive and preventative care models, and conducting therapist training.
“Every 40 seconds, someone dies from suicide; tens of millions more live with mental health conditions for which there is no good standard of care. The launch of our phase 3 clinical study in treatment-resistant depression here in the UK is an important step in developing innovations that are urgently needed, and we recognize the important role that public-private partnerships play in this. We’re proud to partner with South London and Maudsley NHS Foundation Trust and King’s College London to open the new Centre for Mental Health Research and Innovation. Together, we are conducting cutting-edge research to develop new solutions for mental illnesses and ensure these potential treatments are broadly and equitably accessible to those who need them the most.”
-Kabir Nath, CEO, Compass Pathways
“We are excited to be running part of this pivotal phase 3 study at the new Centre for Mental Health Research at our Maudsley Hospital site in South London. The newly launched Centre is part of a research partnership which will help to develop innovative treatment with the goal of improving mental health care for people across the UK. Our world-leading clinicians will work closely with researchers at the new Centre and will begin with a focus on areas of urgent need, such as anorexia nervosa and treatment-resistant depression.”
-David Bradley, Chief Executive of South London and Maudsley NHS Foundation Trust
“Today marks a milestone for research into the use of psychedelics to treat mental health conditions. Over several years we have moved to phase 3 clinical trials for psilocybin and treatment-resistant depression, an achievement that would not have been possible without the facilities and staff of the NIHR King’s Clinical Research Facility. Now with this new Centre, the continuing partnership between Compass Pathways, King’s College London and South London and Maudsley is embarking on the next stage of research where we can evaluate the safety and effectiveness of psychedelics to treat a range of mental health conditions, explore the mechanisms behind how psychedelics might work and assess the feasibility for their delivery at scale.”
-Allan Young, Head of Academic Psychiatry, at King’s College London
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomized, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing 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. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. Compass Pathways is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing.