Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health,  announced that an initial data readout showed that investigational COMP360 psilocybin treatment was well-tolerated in a phase 2 clinical trial of people living with post-traumatic stress disorder (PTSD). This is believed to be the first study reporting on the feasibility of psilocybin as a potential treatment for PTSD.

The open-label study evaluated the safety and tolerability of COMP360 psilocybin treatment in patients with PTSD as a result of trauma experienced as adults. 22 participants received a single 25mg dose of investigational COMP360 psilocybin treatment. The initial data readout, based on monitoring patients at 24 hours post COMP360 administration, indicated that COMP360 was well-tolerated and the safety profile was as expected, with no treatment emergent serious adverse events recorded.

In line with the study design, participants are being monitored for a 12-week period post dosing. Safety and efficacy data over that period are expected to be announced in spring 2024. The study is being conducted in the UK and US at The Institute of Psychiatry, Psychology & Neuroscience at King’s College London, Icahn School of Medicine at Mount Sinai, New York City and Sunstone Therapies, Rockville, Maryland.

Dr Guy Goodwin, Chief Medical Officer, Compass Pathways, said: “Safety is of paramount importance when developing potential new treatments, so we are pleased to see these positive safety signals. These results are consistent with findings from other studies and add to the growing body of evidence to demonstrate the potential of COMP360 in difficult-to-treat mental health conditions.”

Dr James Rucker, Consultant Psychiatrist and Lead of the Psychoactive Trials Group at King’s College London, said: “PTSD is a very distressing condition and existing treatments are not always effective. It’s encouraging to see these initial safety results for COMP360 psilocybin treatment in this patient population and we look forward to a more detailed analysis of the study next year.”