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    Wednesday, July 2, 2025

    STAT+: Psychedelic therapy shows promise in mid-stage study in treatment-resistant depression

    An experimental psychedelic therapy from the U.K. company Beckley Psytech significantly reduced symptoms of treatment-resistant depression in a mid-stage trial, newly released data show, raising expectations for a class of drugs racing toward potential approval by U.S. regulators. 

    Companies like Beckley, Atai Life Sciences, and Compass Pathways — the first two are in the process of merging — are now vying to bring psychedelic therapies to market at a time when the regulatory and political climate seems to be shifting. The industry has backing from members in both parties, and several psychedelics-friendly figures have been appointed to policy roles under health secretary Robert F. Kennedy Jr. 

    In a Phase 2b clinical trial, Beckley’s compound, BPL-003 — an intranasal formulation of mebufotenin, a short-acting compound related to the psychedelic DMT — led to a reduction of 12.1 and 11.1 points on a standard clinical measure of depression called the MADRS scale at day 29, depending on dose. That compares to a 5.8 reduction in the low-dose comparator group, meeting the trial’s primary and key secondary endpoints. There were 193 participants in the study.

    Continue to STAT+ to read the full story…

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