Beckley’s 5-MeO-DMT shows rapid, durable antidepressant effects in phase 2b study

Psychedelic Alpha have written a thoughtful and very informative piece about recent 5-MeO-DMT research, commenting: “British psychedelic drug developer Beckley Psytech has shared topline data from a Phase 2b study of its lead candidate, intranasal 5-MeO-DMT (BPL-003), in treatment-resistant depression (TRD). The results were released this morning by way of a joint announcement with atai Life Sciences, which is set to acquire Beckley following the successful results.  The headline finding is that the short-acting psychedelic, delivered alongside psychological support, occasioned a rapid and significant antidepressant effect, with participants exposed to the highest dose (12 mg) seeing mean 11.1-point greater MADRS reduction than those in the low-dose group (0.3 mg) at day 29. While that was the primary endpoint, the mid-dose group (8 mg) actually fared slightly better, with a low-dose-subtracted MADRS score decrease of 12.1.  Given that data, Beckley intends to move ahead with the 8 mg dose, pending discussions with FDA. On the safety front, the company reports that the drug was “generally well-tolerated at all doses”, with no drug-related serious adverse events (SAEs), including no instances of treatment-emergent suicidal intent or behaviour in the mid- and high-dose arms. Here, we take a closer look at the readout as well as how it stacks up against the company’s closest competitor, GH Research, which is developing the same drug for the same indication.”

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