BioCentury
ARTICLE | Product Development

Compass’ psilocybin therapy meets endpoint — investors skeptical

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June 25, 2025 1:01 AM UTC

The inability to maintain blinding in clinical trials of psychedelic therapies is not an insurmountable obstacle for sponsors, but the surest way to counter criticisms of functional unblinding and expectation bias skewing the clinical results is for therapeutic candidates to generate large and durable effect sizes. If a clinical benefit is big enough, it becomes hard to argue that it’s entirely due to bias.

Compass Pathways plc (NASDAQ:CMPS) reported Monday that a single, 25 mg dose of its psilocybin therapy COMP360 met the primary endpoint in a Phase III trial in patients with treatment-resistant depression, producing a mean difference of -3.6 points versus placebo (p<0.001) at six weeks on the Montgomery-Åsberg Depression Rating Scale (MADRS). ...