Atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech recently announced positive topline results from a phase 2b study of BPL-003 in patients with treatment-resistant depression (TRD). The study, which included 193 patients, met its primary and all key secondary endpoints. Both the 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to week 8.
The study demonstrated that BPL-003 was generally well-tolerated at all doses, with more than 99% of treatment-emergent adverse events being mild or moderate, and no drug-related serious adverse events or suicide-related safety signals. The majority of patients were deemed ready for discharge at the 90-minute post-dose assessment, suggesting that BPL-003 could fit within the existing 2-hour in-clinic interventional psychiatry treatment paradigm.
The safety and efficacy data support the selection of the 8 mg dose to advance into phase 3 clinical development, pending consultation with regulatory authorities. The study is the largest controlled study of mebufotenin and the only blinded phase 2 study of mebufotenin to include the United States.
Key efficacy findings include a statistically significant reduction in depressive symptoms with both the 8 mg and 12 mg doses of BPL-003, with effects generally maintained out to week 8. The 8 mg and 12 mg doses demonstrated equivalent efficacy, suggesting that the 8 mg dose may be sufficient to achieve therapeutic benefit from a single dose. Additionally, both higher doses showed a durable effect, with a mean reduction of 10.8 points from baseline at day 57 in the 8 mg group and a mean reduction of 10.2 points from baseline in the 12 mg group compared with the 0.3 mg group.
On the safety front, BPL-003 was generally well-tolerated at all doses, with more than 99% of treatment-emergent adverse events being mild or moderate, and no drug-related serious adverse events. The average time to meet readiness for discharge criteria across all arms was within two hours of dosing, and the study had a low drop-out rate with 90% of patients completing the core study.
The companies plan to engage with the U.S. Food and Drug Administration (FDA) and other applicable agencies regarding the phase 3 trial design for patients with treatment-resistant depression in the coming months. The Phase 2b study achieved its pre-agreed success criteria for the proposed strategic combination between Atai and Beckley Psytech, and the strategic combination is now expected to progress to Atai shareholder approval stage.
The conference call to discuss these results is scheduled for 8:00 am EDT on July 1, 2025.
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, with a short time in the clinic, and is being investigated as a potential therapy for TRD and for alcohol use disorder (AUD).
Depression affects nearly 300 million people across the globe, 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 and may affect up to 50% of those living with depression, creating a significant unmet need for more effective treatments.
Atai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. Its pipeline of psychedelic-based therapies includes VLS-01 (buccal film DMT) for treatment-resistant depression (TRD) and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in phase 2 clinical development. Beckley Psytech, on the other hand, is dedicated to improving the lives of people living with neuropsychiatric disorders by developing rapid-acting psychedelic medicines. As a result of these announcements, the company's shares have moved -0.46% on the market, and are now trading at a price of $2.19. For the full picture, make sure to review ATAI Life Sciences's 8-K report.
