Atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech Limited recently released positive data from a proof-of-concept study on a two-dose induction regimen of BPL-003, an intranasal mebufotenin benzoate, in patients with treatment-resistant depression (TRD). The open-label phase 2a study enrolled 13 patients, with 12 meeting the criteria for per-protocol analysis. Here are the key findings from the study:
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Rapid and Durable Efficacy: After the first 8 mg dose, patients experienced a mean reduction of 13.3 points in MADRS (Montgomery-Asberg Depression Rating Scale) scores 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 (13.7 points from baseline).
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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 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.
The data from this study, along with the results from Beckley Psytech’s phase 2b study of BPL-003, will be used to inform the phase 3 clinical program. The results also add to the growing body of evidence demonstrating that BPL-003 has the potential to be a rapid-acting, durable, and convenient treatment option for patients with TRD.
Beckley Psytech's CEO, Cosmo Feilding Mellen, highlighted the potential of BPL-003 to offer a rapid, well-tolerated, and durable treatment option for patients with TRD, emphasizing the consistent results across different studies. The company is finalizing plans to engage with regulatory agencies to discuss the design of the phase 3 clinical trial for BPL-003, with initiation expected in the first half of 2026 pending FDA feedback.
BPL-003 is a patent-protected, proprietary intranasal formulation of mebufotenin benzoate, designed to deliver rapid and durable effects from a single dose, with a short treatment window. It is being investigated as a potential therapy for TRD and for alcohol use disorder (AUD).
The study's findings provide compelling evidence that a two-dose induction regimen for BPL-003 may optimize outcomes for patients with TRD, and this dosing approach could be explored further in phase 3 studies, subject to discussions with regulators. As a result of these announcements, the company's shares have moved -1.41% on the market, and are now trading at a price of $4.88. Check out the company's full 8-K submission here.
