COMPASS Pathways has reported positive topline results from its phase 2b trial of a psilocybin-based therapy for depression.
For the randomized, double-blind study, patients were given either a 25mg, 10mg or 1mg dose. According to the UK-based company, at least twice the number of patients in the 25mg group showed response and remission at weeks three and 12, compared to the 1mg group. Patients in the 10mg group did not show a statistically significant difference from the 1mg group at week three.
The study involved 233 patients, making it the largest ever clinical trial involving psilocybin, the active ingredient in “magic mushrooms.” For the study, COMPASS zeroed in on patients suffering from treatment-resistant depression, which is characterized by an inadequate response to two or more traditional antidepressants, and impacts more than 100 million people worldwide.
The therapy, called COMP360, was generally well tolerated by participants. COMPASS reported that 90% of incidents involving adverse events, such as nausea, headache or fatigue, were mild to moderate in severity.
To develop the psychedelic or other traditional “party drugs” that are now in clinical trials to treat mental health conditions, researchers have typically removed the molecule that makes the substance mind-altering. But for COMPASS’ treatment, the psychedelic trip is part of the therapy. To receive the treatment, patients have to spend about six hours at a clinic with trained therapists who sit with them throughout the experience. If it’s ever approved, the complexities of administering the drug in this way could lead to challenges with its rollout.
COMPASS said that the trial was designed to help determine the best dose for a larger, pivotal trial, which it hopes to launch next year.
