Compass Pathways release positive topline results from its phase 2b clinical trial of COMP360 psilocybin therapy for treatment-resistant depression. The trial achieved its primary endpoint for the highest dose tested, 25 mg, demonstrating a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with rapid and durable treatment response. Based on these results a pivotal phase 3 program is expected to begin in 2022.
Psilocybin therapy is an approach the company has developed to combat mental health challenges. The therapy combines the pharmacological effects of psilocybin, a psychoactive substance, with psychological support. Psilocybin is an active ingredient in some species of mushrooms, often referred to as “magic mushrooms”. COMP 360 is a synthesized formulation of psilocybin.
The randomized, controlled, double-blind phase 2b trial evaluated a single dose of COMP360 psilocybin in 233 patients in conjunction with psychological support from specially trained therapists. All patients discontinued antidepressants prior to participation. The trial was powered to compare two active doses of COMP360, 25mg and 10mg, aga...
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