Compass Pathways Psilocybin Trial for Treatment-Resistant Depression Shows Positive Results

Compass Pathways this week shared results of a Phase IIb clinical trial of its COMP360 psilocybin, administered in combination with psychological support, for patients with treatment-resistant depression (TRD).

The combination of a 25-mg dose of COMP360 and psychological support demonstrated a statistically significant and clinically relevant reduction in depressive symptom severity after 3 weeks.

In a randomized, controlled, double-blind trial, a single dose of investigational COMP360 psilocybin and psychological support from specially trained therapists were given to 233 patients from 10 countries in North America and Europe. The trial compared dosage amounts of COMP360 psilocybin with 25mg and 10mg doses, and a comparator 1mg dose. After 3 weeks, the 25mg group showed a statistically significant difference on the MADRS depression scale, while the 10mg group did not.

The medication was generally well tolerated, with more than 90% of treatment-emergent adverse events being mild or moderate. The most common events reported by patients were headache, nausea, fatigue, and insomnia.

“This is the largest modern study of a psychedelic drug, combined with psychological support, enrolling over 200 people with TRD,” David J Hellerstein MD, a principal investigator on the trial and professor of clinical psychiatry at the Columbia University Irving Medical Center, said in a news release.

“In this groundbreaking study, a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks. Remission rates appear to be higher than seen in traditional medication studies. We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder. These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”

In its news release, Compass said it expects to continue its research with a larger Phase III trial slated to begin in 2022.