First patient dosed in Beckley Psytech’s Phase IIa study of BPL-003 in combination with SSRIs for Treatment Resistant Depression
The Phase IIa trial is a two-part, open-label study investigating the safety, tolerability and pharmacodynamics of BPL-003, Beckley Psytech’s novel, synthetic intranasal formulation of 5-MeO-DMT, in patients with Treatment Resistant Depression (TRD). Part 1 of the study was in patients who were not taking antidepressants. Initial results from that part, shared in March 2024, showed that a single dose of BPL-003 was safe and well-tolerated, with a rapid and durable antidepressant effect lasting up to 85 days post-dose. The first patient has now been dosed in Part 2 of the study, which will assess a single dose administration of BPL-003 in TRD patients who are also taking SSRI antidepressants in order to understand the effects of BPL-003 as an adjunctive therapy to SSRIs. Initial results from Part 2 of this study are expected in H1 2025.
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