Atai and Beckley Psytech Report Positive Phase 2b Results for BPL‑003

LOS ANGELES- Atai Life Sciences and Beckley Psytech have announced positive topline results from their Phase 2b clinical trial of BPL‑003, an intranasal formulation of mebufotenin benzoate, in patients with treatment‑resistant depression (TRD). The multicenter, randomized, quadruple‑masked study involved 193 patients across six countries and met its primary endpoint: a single dose (8 mg or 12 mg) produced statistically significant and clinically meaningful reductions in depressive symptoms on the MADRS scale by Day 29 compared to a low-dose control (0.3 mg). Both doses demonstrated rapid onset—improvements detected 24 hours after dosing—and sustained effects up to the eight‑week endpoint. The safety profile was favorable, with 99% of treatment‑emergent adverse events classified as mild or moderate and no serious drug‑related or suicide‑related events reported. Additionally, most patients were cleared for discharge within 90 minutes post‑dose, aligning with in‑clinic treatment models such as Janssen’s Spravato®.

The favorable outcomes unlock the pre‑agreed criteria for the proposed all‑share merger between Atai and Beckley Psytech, expected to progress to shareholder approval soon. With the data in hand, the companies plan to engage regulators—primarily the U.S. Food and Drug Administration—this year to initiate Phase 3 trials, advancing BPL‑003 as a potential new therapeutic for TRD. Analysts note that this asset could address a substantial unmet need among patients not responding to conventional antidepressants, and its rapid, durable efficacy paired with an efficient in‑clinic treatment schedule may enhance commercial viability.