Following promising Phase 2b results, Atai Life Sciences has announced plans to merge with Beckley Psytech to advance short-duration psychedelic treatments for mental health.
A planned merger between Atai Life Sciences and Beckley Psytech has been triggered after Beckley’s psychedelic nasal spray, BPL-003, demonstrated rapid and durable antidepressant effects in a Phase 2b trial targeting treatment-resistant depression (TRD).
The study tested intranasal mebufotenin (5-MeO-DMT) at 8 mg and 12 mg doses, compared to a 0.3 mg comparator, in 193 patients. Both active doses showed statistically significant improvements in depression symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), a common clinical benchmark for depression severity.
- A single 12-mg dose led to an 11.1-point reduction in MADRS scores at Day 29
- The 8-mg dose showed a 12.1-point reduction, meeting a key secondary endpoint
- Improvements were seen as early as Day 1 and sustained through 8 weeks
Importantly, the trial reported no serious safety issues or suicide-related adverse events. 99% of side effects were mild or moderate, supporting the treatment’s tolerability.
With these results, Atai Life Sciences is moving ahead with its planned merger with Beckley Psytech. The combined entity, Atai Beckley, aims to become a global leader in short-duration psychedelic-based mental health therapies, according to a July 1 announcement.
“A single 8 mg or 12 mg dose of BPL-003 demonstrated favorable tolerability, quick and long-lasting efficacy, and a brief in-clinic duration,” said Cosmo Feilding Mellen, CEO of Beckley Psytech. “We look forward to end-of-phase 2 meetings with regulators.”
BPL-003’s short action time may help it fit seamlessly into existing interventional psychiatry models, such as the two-hour protocol used by Johnson & Johnson’s Spravato (esketamine nasal spray)—the current market leader in nasal depression treatments. In Beckley’s trial, most patients were ready for discharge just 90 minutes after dosing.
This news comes at a pivotal moment for the psychedelics field. In 2024, Lykos Therapeutics’ MDMA-based therapy for PTSD was denied FDA approval—casting a shadow over the sector. However, the space is rebounding, with Compass Pathways recently announcing positive results from its Phase 3 psilocybin trial.
The Atai–Beckley deal adds further momentum, indicating that regulated, clinic-based psychedelic therapies are gaining ground in the pursuit of fast-acting, durable treatments for mental health disorders.
