Beckley Psytech and atai Life Sciences have announced that a Phase 2b trial of Beckley’s BPL-003 intranasal mebufotenin (5-MeO-DMT) in patients with treatment-resistant depression met its primary endpoint, demonstrating a significant reduction in symptoms of depression for both doses tested. According to the companies, the trial, which was initiated in September 2023, also met all secondary endpoints. Based on the results, Beckley and Atai say that they plan to advance the 8 mg dose BPL-003 into Phase 3 development for this indication.
In addition to moving forward with development of the nasal spray, the companies will also move ahead with creation of a combined company, with the new company called atai Beckley. Atai announced in January 2024 that it had acquired approximately 35% of Beckley Psytech, and it will now acquire the remaining shares.
The Phase 2b study enrolled 193 patients with moderate-to-severe treatment-resistant depression who received a single dose of either 8 mg of BPL-003, a 12 mg dose of BPL-003, or a 0.3 mg dose. Symptoms were assessed using the Montgomery-Åsberg depression rating scale at Day 2, Day 8, Day 29 and Day 57. Patients receiving the 12 mg dose had a mean decrease of 11.1 points from baseline at Day 29, with a 12.1 mean decrease for patients receiving the 8 mg dose, and a 5.8 point mean decrease in the 0.3 mg group.
No safety concerns were identified, the companies said, and 90% of participants completed the study. An 8-week open label extension, which is evaluating a second dose of the 12 mg dose only, has enrolled 85% of eligible participants from the main trial.
Beckley Psytech CEO Cosmo Feilding Mellen commented, “The achievement of our primary and secondary endpoints in this study represents an important milestone in the development of BPL-003 and reinforces its potential to be a viable treatment option for patients and healthcare systems. We are particularly encouraged that a single 8 mg or 12 mg dose of BPL-003 showed rapid and durable efficacy results, favorable tolerability and a short time in-clinic, giving us important flexibility in optimizing the design of future trials. Thank you to all of the patients and study partners who participated in this study – we now look forward to preparing for end-of-Phase 2 meetings with regulators and moving forward with our strategic combination with atai Life Sciences to form atai Beckley, a global leader in psychedelic-based mental health treatments.”
Atai CEO Srinivas Rao said, “These findings strengthen our confidence in the potential of BPL-003 to be a transformative psychedelic therapy, offering rapid and durable antidepressive effects with minimal in-clinic time for patients with treatment-resistant depression. We look forward to engaging with the regulators later this year to advance this innovative treatment into Phase 3 clinical development.”
Read the Beckley Psytech and Atai Life Sciences press release
