AtaiBeckley sets Q2 2026 start for Phase 3 pivotal BPL-003 trials
AtaiBeckley will initiate two parallel Phase 3 trials of its mebufotenin benzoate nasal spray BPL-003 for treatment-resistant depression in Q2 2026 after FDA End-of-Phase 2 feedback and Breakthrough Therapy Designation. The ReConnection trials include a 12-week randomized, placebo-controlled core and 52-week open-label extension with retreatment criteria.
1. Phase 3 Trial Plans
AtaiBeckley confirmed it will launch two parallel Phase 3 pivotal studies, ReConnection-1 and ReConnection-2, in the second quarter of 2026 following a successful End-of-Phase 2 meeting with the FDA and receipt of Breakthrough Therapy Designation for BPL-003.
2. Trial Design and Endpoints
Each ReConnection study features a 12-week randomized, double-blind, placebo-controlled core period to assess rapid antidepressant effects, followed by a 52-week open-label extension allowing individualized retreatment based on pre-specified clinical criteria.
3. Phase 2b Topline Results
In Phase 2b trials, a single dose of BPL-003 delivered rapid antidepressant effects within two days and maintained improvements for up to eight weeks, with response and remission rates increasing after an optional second dose during open-label extension.
4. Commercial Readiness Strategy
AtaiBeckley is developing a rollout model for BPL-003 that fits existing interventional psychiatry workflows—similar to Spravato—without requiring in-session psychotherapy, aiming for patient convenience and operational scalability.