Beckley Psytech reports positive results in trial of treatment-resistant depression drug
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Key takeaways:
- 55% of patient with treatment-resistant depression experienced a rapid response to a single dose of BPL-003.
- Remission from depression persisted among 45% of patients at day 85.
More than half of patients with treatment-resistant depression achieved response with a single dose of BPL-003, a benzoate salt formulation of 5-MeO-DMT that is administered intranasally, according to a press release from the manufacturer.
Results also showed the acute effects of treatments resolved quickly, suggesting that use of 5-MeO-DMT (mebufotenin) may have a lower health care resource burden than other psychedelic treatments currently under evaluation for depression, Beckley Psytech reported in the release.
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In a phase 2a open-label clinical study of 12 patients with moderate to severe treatment-resistant depression (TRD), 55% of patients who received a single 10 mg dose of BPL-003 (Beckley Psytech) alongside psychological support experienced a rapid antidepressant response the day following treatment, measured using the Montgomery–Åsberg Depression Rating Scale.
Additionally, 55% of patients were in remission from depression at day 29 and 45% were in remission at day 85.
These results reveal that a single dose of BPL-003 is both durable and effective among patients with TRD, according to the press release.
Also, treatment appeared to be well-tolerated and 95% of adverse events were mild or moderate, according to the release.
The company said It is now enrolling patients who regularly take antidepressants in an extension of this phase 2a study to evaluate the safety and efficacy of BPL-003 as an adjunctive treatment.
Further, an ongoing phase 2b study is evaluating how 225 patients with TRD respond to a medium or high sub-perceptual dose of BPL-003, with initial results anticipated in the second half of 2024, serving as the largest and only FDA-approved phase 2b study of 5-MeO-DMT.
“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,” Beckley Psytech CEO Cosmo Feilding Mellen said in the release. “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.”