atai Life Sciences announced that the first patient has been dosed in Part 2 of Beckley Psytech’s Phase 2a study, evaluating BPL-003 in patients living with Treatment Resistant Depression, TRD. In Part 2 of this open-label Phase 2a study, patients with moderate-to-severe TRD who are on a stable course of certain oral selective serotonin reuptake inhibitor antidepressants will receive a single dose of BPL-003 alongside psychological support to explore the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BPL-003 as an adjunctive therapy to SSRIs. Patients will be followed for 12 weeks post-dosing. Initial results are expected in H1 2025. Commenting on Part 2 of the trial, Florian Brand, CEO and Co-Founder of atai, said: “Many clinical trials investigating psychedelics require patients to discontinue their existing antidepressant medication. The findings from this adjunctive therapy part of the BPL-003 Phase 2a study will help to inform whether BPL-003 could be a safe and effective therapy in combination with SSRIs, which could allow for broader patient access, should BPL-003 reach approval.”
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