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Investing.com -- Compass Pathways Plc (NASDAQ:CMPS) stock plunged 35.2% after the biotechnology company announced results from its Phase 3 COMP005 trial for COMP360, its synthetic psilocybin formulation for treatment-resistant depression (TRD).
Despite meeting its primary endpoint with a statistically significant reduction in depression symptoms compared to placebo (p<0.001), investors appeared disappointed by the modest clinical benefit. The trial showed a -3.6 point difference in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at week 6 between patients receiving a single 25mg dose of COMP360 and those receiving placebo.
The Phase 3 COMP005 trial, which dosed 258 participants across 32 U.S. sites, represents the first study of synthetic psilocybin and the first classic psychedelic to report Phase 3 efficacy data for depression treatment. According to the Data Safety Monitoring Board, safety findings were consistent with previous studies of COMP360 with no new or unexpected safety concerns.
Kabir Nath, CEO of Compass Pathways, characterized the results as showing "innovative potential of psilocybin treatment in mental health care," while noting the company anticipates further insights from the full dataset and from the ongoing COMP006 trial, which will explore two fixed doses.
The company plans to discuss these preliminary data with the FDA, which has not yet reviewed the results. Compass Pathways continues to position COMP360 as a potential option for patients who have failed multiple currently approved treatments for depression.
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