Atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech Limited have released positive data from a phase 2a study of BPL-003, an intranasal mebufotenin benzoate, in patients with treatment-resistant depression (TRD). The study evaluated a two-dose induction regimen of BPL-003 (8 mg followed by 12 mg two weeks later) in 13 TRD patients and demonstrated rapid, clinically meaningful, and durable antidepressant effects, sustained for up to 3 months.
The key findings from the study include: Rapid and durable efficacy: Patients experienced a mean MADRS reduction of 13.3 points from baseline at day 2 after the first 8 mg dose, 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. 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 8mg dose were 25%, doubling to 50% at week 8 and 42% at week 12. 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. 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.
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. The results from the study, along with data from the phase 2b program, will be used to inform the phase 3 clinical program.
The study's results 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. Pending FDA feedback, initiation of phase 3 trials for BPL-003 in patients with TRD is expected in the first half of 2026.
BPL-003 is Beckley Psytech’s 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).
Depression affects nearly 300 million people globally, with around 52 million people affected by the condition in Europe and the US combined. Treatment-resistant depression occurs when an individual does not respond to two or more courses of antidepressants, affecting up to 50% of those living with depression.
Atai Life Sciences is a clinical-stage biopharmaceutical company focused on developing highly effective mental health treatments. Its pipeline of psychedelic-based therapies includes VLS-01 for TRD and EMP-01 for social anxiety disorder, both in phase 2 clinical development.
Beckley Psytech Ltd is a private biopharmaceutical company dedicated to developing rapid-acting psychedelic medicines to improve the lives of people living with neuropsychiatric disorders.
The companies are finalizing plans to engage with the FDA and other regulatory agencies to discuss the design of the phase 3 clinical trial for BPL-003 in patients with TRD. Following these announcements, the company's shares moved 11.88%, and are now trading at a price of $5.46. Check out the company's full 8-K submission here.
