Compass Pathways has confirmed that the UK component of its Phase 3 trial investigating psilocybin for treatment-resistant depression has now launched.
The trial will be carried out at multiple sites in the UK, including at the Centre for Mental Health Research and Innovation in London, which officially opened on 15 November, 2023.
The ongoing Phase 3 programme is the largest randomised, 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 programme 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 at 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.
CEO of Compass Pathways, Kabir Nath, commented: “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 recognise the important role that public-private partnerships play in this.”
The Centre for Mental Health Research and Innovation
One of the sites where the trial will take place is 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.
Nath stated: “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.”
David Bradley, Chief Executive of South London and Maudsley NHS Foundation Trust, commented: “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.”
Professor Allan Young, Head of Academic Psychiatry, at King’s College London said: “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.”
