atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced that patient enrollment has been completed in Beckley Psytech’s Phase 2b trial evaluating BPL-003 in treatment-resistant depression (TRD), with topline results expected by mid-2025.
The trial is assessing the efficacy and safety of a single dose of BPL-003, an intranasal formulation of mebufotenin benzoate developed by Beckley Psytech, in which atai is invested, designed for rapid and lasting antidepressant effects with minimal clinic time.
The eight-week, double-blind, dose-finding core stage has enrolled 196 patients with moderate-to-severe TRD across 38 sites in six countries.
The trial compares medium (8mg) and high (12mg) doses against a sub-perceptual dose, with efficacy measured using the Montgomery-Asberg Depression Rating Scale (MADRS).
An open-label extension stage continues to enroll patients to evaluate the safety and efficacy of a second high dose.
This follows promising results from the Phase 2a study, where a single 10mg dose of BPL-003 led to rapid and sustained antidepressant effects, with 55% of patients achieving remission at Day 29 and 45% maintaining remission at Day 85.
Patients in that study were deemed ready for discharge within an average of under two hours after dosing.
“We are impressed by the Beckley Psytech team’s execution of the Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression, which is the largest controlled trial of mebufotenin and the first and only Phase 2b clinical trial to investigate mebufotenin in the US,” atai CEO Dr Srinivas Rao said in a statement.
“The promising data from earlier clinical studies of BPL-003 have demonstrated that a single dose can induce rapid, significant, and lasting antidepressant effects, further reinforcing our confidence in its potential to revolutionize treatment for difficult-to-treat depression.”
Shares of atai rose around 3.4% on Wednesday in New York.