atai Life Sciences (ATAI) and Beckley Psytech announced positive data from a proof-of-concept study investigating a two-dose induction regimen of BPL-003, in patients with treatment-resistant depression, TRD. The open-label Phase 2a study enrolled 13 patients with TRD who were not on concurrent antidepressants, and 12 met the criteria for per-protocol analysis. Patients were given an 8 mg dose of BPL-003 followed by a 12 mg dose two weeks later. Safety, tolerability and efficacy assessments were conducted at various timepoints for 12 weeks following the initial dose using multiple validated depression rating scales including the MADRS. The results demonstrate that a second dose of BPL-003 at Week 2 has the potential to induce greater antidepressant effects, as evidenced by additional reductions in MADRS scores, without impact on the safety and tolerability profile of the treatment.
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