atai Life Sciences announces positive topline data from treatment-resistant depression study
Last updated: 10:41 20 May 2025 EDT, First published: 08:41 20 May 2025 EDT
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced positive topline data from Part 2 of Beckley Psytech’s Phase 2a study of BPL-003, an intranasal formulation of mebufotenin benzoate, in combination with selective serotonin reuptake inhibitors (SSRIs) for treatment-resistant depression (TRD).
The open-label Phase 2a study evaluated the safety, efficacy, and pharmacokinetics of a single dose of BPL-003 in 12 patients with moderate-to-severe depression who had not responded to at least two prior treatments and were taking SSRIs.
The patients were followed for 12 weeks post-dosing, with multiple assessments conducted throughout the study.
The results showed that a single dose of BPL-003 produced a rapid and durable antidepressant effect lasting up to three months.
A mean reduction of 18 points in MADRS (Montgomery-Asberg Depression Rating Scale) scores was observed the day after dosing, 19 points at one month, and 18 points at three months.
atai also noted that BPL-003 was well-tolerated. All adverse events were mild or moderate in severity, with no serious adverse events reported.
The findings support the results from Part 1 of the study, which assessed BPL-003 as a monotherapy and also demonstrated rapid and lasting antidepressant effects.
“We’re very encouraged by the growing body of data supporting BPL-003 as a potentially differentiated and commercially scalable interventional psychiatric treatment for depression,” atai CEO Srinivas Rao said in a statement.
“Patients with treatment-resistant depression face limited options and these results show that a single dose of BPL-003 can deliver rapid and durable antidepressant effects when co-administered with an SSRI, extending the positive results observed in the Part 1 monotherapy study.”
Data from the core, randomized, quadruple-masked stage of Beckley Psytech’s Phase 2b study of BPL-003 in TRD is expected in mid-2025.
The study enrolled 196 patients and is the largest controlled clinical study to date investigating mebufotenin, as well as the only blinded Phase 2b study of the compound in the United States. The results from this study will support end-of-Phase 2 regulatory discussions and inform Phase 3 planning.
Shares of atai moved higher on the news, climbing more than 7.6% on Tuesday morning.
