Beckley Psytech says that more than half of people with moderate-to-severe treatment resistant depression who received a single 10mg dose of BPL-003 intranasal synthetic dry powder 5-MeO-DMT (mebufotenin) in a Phase 2a trial experienced a reduction in depressive symptoms and almost half remained in remission at day 85 post dose. The Phase 2a study, which was initiated in December 2022, enrolled 12 subjects, with 11 included in per-protocol analysis.
According to the company, patients were able to be discharged an average of less than 2 hours following dosing, and “BPL-003 was generally well-tolerated, with convenient nasal administration. 95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent” with the results from a Phase 1 study of the nasal powder reported in November 2022.
Beckley says that an extension of the study is currently enrolling treatment resistant depression patients who are taking oral antidepressants. A Phase 2b trial of BPL-003 was initiated in October 2023, and initial results are expected this year.
Florian Brand, CEO of Atai Life Sciences, which recently made a strategic investment in Beckley, said, “We are thrilled with the progress the Beckley Psytech team has made on the BPL-003 program. The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year. With around half of TRD patients in remission three months after just a single dose of BPL-003 in this study, we are particularly excited about its antidepressant durability potential. The results indicate that BPL-003 could offer a scalable, single-dose administration within the two hour in-clinic treatment paradigm successfully established by Spravato.”
Beckley CEO Cosmo Feilding Mellen commented, “We are delighted to see that a single dose of BPL-003 delivered a rapid and durable antidepressant response in patients with treatment resistant depression. Our single dose treatment model enables a short treatment duration which positions BPL-003 as a potentially exciting and scalable treatment opportunity. Less than 15% of patients with treatment resistant depression achieve long-term remission with the current standard of care, and we look forward to further validating the potential of BPL-003 as a treatment option with our ongoing Phase 2b study and subsequent clinical development program.”
Read the Beckley Psytech press release.
Read the Atai Life Sciences press release.
