Atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech have reported positive results from a phase 2a study of BPL-003 in patients with treatment-resistant depression (TRD). The open-label study evaluated a two-dose induction regimen of BPL-003 (8 mg followed by 12 mg two weeks later) and demonstrated rapid, clinically meaningful, and durable antidepressant effects sustained for up to 3 months.
Key findings from the study include:
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Rapid and durable efficacy: Following the first 8 mg dose, patients experienced a mean reduction of 13.3 points in MADRS (Montgomery-Asberg Depression Rating Scale) score from baseline at day 2 and a mean reduction of 12.9 at day 8. One week after the second 12 mg dose, there was a further decrease in MADRS score to a total of a 19.0-point reduction from baseline, with sustained antidepressant effects observed through week 12.
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Improved response and remission rates: The second dose of BPL-003 increased the proportion of patients meeting response and remission criteria for depression. Remitter rates one week after the initial 8 mg dose were 25%, doubling to 50% at week 8 and reaching 42% at week 12.
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Strong and consistent tolerability profile: BPL-003 was generally well-tolerated, with all adverse events classified as mild to moderate, and no severe or serious drug-related adverse events reported.
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Practical administration: Patients met discharge readiness criteria within two hours after dosing for both doses, reinforcing the potential for BPL-003 to be integrated into the established interventional psychiatric treatment paradigm.
These results underline BPL-003’s potential to offer a rapid, well-tolerated, and durable treatment option for patients with TRD. The findings are consistent with results from earlier phase 2a cohorts, including studies in patients who were taking antidepressants, where a single dose of BPL-003 produced rapid and sustained improvements for up to three months.
Atai and Beckley Psytech are finalizing plans to engage with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to discuss the design of the phase 3 clinical trial for BPL-003 in patients with TRD. Pending FDA feedback, initiation of phase 3 trials is expected in the first half of 2026.
BPL-003 is Beckley Psytech’s patent-protected, proprietary intranasal formulation of mebufotenin benzoate, administered via a nasal spray device. It is designed to deliver rapid and durable effects from a single dose and is being investigated as a potential therapy for TRD and for alcohol use disorder (AUD).
These results add to the growing body of evidence from the BPL-003 clinical program, demonstrating its potential as a rapid-acting, durable, and convenient treatment option for patients with TRD. Today the company's shares have moved 11.88% to a price of $5.46. For the full picture, make sure to review ATAI Life Sciences's 8-K report.
