Compass Pathways announced that the company has launched the U.K. component of its Phase 3 study of COMP360 psilocybin for treatment-resistant depression (TRD). The research will take place in multiple sites in the United Kingdom, including at the Centre for Mental Health Research and Innovation in London, which officially opened in November. The ongoing Phase […]
Compass Pathways announced that the company has launched the U.K. component of its Phase 3 study of COMP360 psilocybin for treatment-resistant depression (TRD).
The research will take place in multiple sites in the United Kingdom, including at the Centre for Mental Health Research and Innovation in London, which officially opened in November.
The ongoing Phase 3 program is the largest randomized, controlled, double-blind psilocybin-treatment clinical program ever conducted, according to the company. It comes on the heels of 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. Each trial has an integrated, long-term-outcomes component, London-based Compass noted.
COMP 006 will take place in the United Kingdom and globally and will study three dose arms of COMP360: 25 mg, 10 mg and 1 mg.
COMP 005 is a U.S.-based trial examining the effect of a single 25-mg dose of COMP360 psilocybin, compared with a placebo.
“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,” said Kabir Nath, CEO of Compass Pathways. “The launch of our Phase 3 clinical study in treatment-resistant depression here in the U.K. is an important step in developing innovations that are urgently needed, and we recognize the important role that public-private partnerships play in this.”
Centre for Mental Health Research and Innovation
The COMP 006 trial will be conducted at research sites across the U.K., including at the new Centre for Mental Health Research and Innovation (pictured above).
The facility was established to accelerate psychedelic research and develop new models of care for mental health in the United Kingdom, as part of a 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 initially will focus on areas of urgent need, including TRD and anorexia nervosa, according to Compass.
The center 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.
“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,” Kabir said. “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.”