Compass: Psychedelic Safe, Potentially Effective for PTSD

Compass Pathways has announced that its experimental treatment for post-traumatic stress disorder (PTSD), known as COMP360, has achieved the primary safety objective and several significant efficacy benchmarks in a Phase II clinical trial. COMP360 is a synthetic version of psilocybin, a psychedelic compound that is gaining attention for its potential benefits in treating mental health disorders.

The FDA is also focusing on psychedelics for mental health, scheduling an advisory committee meeting in June to evaluate Lykos Therapeutics' MDMA (midomafetamine) for PTSD treatment. Additionally, Reunion Neuroscience has raised $103 million to begin a Phase II trial for a prodrug similar to psilocybin to treat postpartum depression.

The Phase II study by Compass Pathways involved 22 participants who had PTSD resulting from adult trauma. The trial observed that no serious adverse events occurred, although there were two instances of suicidal ideation. One of these was linked to the study drug and was a moderate, temporary event in a participant who later responded well to the treatment. The other instance was a mild event in a non-responder, deemed possibly related to COMP360. Both participants had a history of suicidality. Common side effects included headaches, nausea, crying, and fatigue.

Beyond safety, COMP360 demonstrated noteworthy improvements in several secondary endpoints. These included changes in PTSD severity, measured by the CAPS-5 scale, and the Sheehan Disability Scale (SDS). A single 25mg dose of COMP360, administered with psychological support, resulted in a 29.5-point average reduction in the CAPS-5 total score from baseline after 12 weeks, along with a 14.4-point reduction in the SDS score over the same period.

Compass Pathways reported that 77.3% of the patients responded to the treatment by week 12, with over half achieving remission. Chief Medical Officer Guy Goodwin commented that these findings, although from a small and open-label study, indicate that COMP360 could offer significant clinical benefits, enhancing daily function and quality of life for patients.