UK-based Compass Pathways Plc has reported positive Phase 3 data for a synthetic psilocybin, and the first classic psychedelic for potential use in treatment-resistant depression. The small molecule drug, COMP360, achieved a clinically meaningful reduction in symptom severity compared with a placebo as measured on the Montgomery-Åsberg Depression Rating Scale, according to the company. Reviewing the safety data, the independent safety monitoring board found no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation between the treatment and placebo arms of the trial. Compass said on 23 June that it plans to discuss the data with the US Food and Drug Administration.
The candidate drug’s active substance, psilocybin, is found in a group of mushrooms known for their psychedelic effects and is subject to restrictions. However Compass has developed a synthesised formulation which has shown to be safe and effective in patients with depression and other mental illnesses.
Psilocybin has a long history, with the first research into its psychedelic effects reported to have taken place in 1799 in London. Almost 200 years later, the FDA approved research in humans but the studies ended and the research didn’t pick up again until the late 1990s. Compass said that its drug was the first classic psychedelic to report Phase 3 efficacy data.
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