atai Life Sciences and Beckley Psytech Announce Positive Topline Results from the Phase 2b Study of BPL-003 in Patients with Treatment-Resistant Depression

Core Insights - The Phase 2b clinical trial of BPL-003 demonstrated significant efficacy and safety in treating treatment-resistant depression (TRD) with a single dose [2][3][12] - A single 12 mg dose resulted in a mean reduction of 11.1 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to a 5.8 point reduction in the 0.3 mg comparator group [2][12] - The strategic combination of atai Life Sciences and Beckley Psytech is expected to create a global leader in psychedelic-based mental health therapies [4][6] Efficacy Findings - The study achieved its primary and all key secondary endpoints, with both 8 mg and 12 mg doses showing statistically significant reductions in depressive symptoms at all time points [6][12] - At Day 29, the 8 mg dose showed a mean MADRS score reduction of 12.1 points compared to the 0.3 mg control (p=0.0025) [2][12] - Improvements in MADRS scores were observed as early as one day after dosing, with effects maintained up to Week 8 [2][6] Safety Findings - BPL-003 was generally well-tolerated, with over 99% of treatment-emergent adverse events being mild or moderate [6][12] - No drug-related serious adverse events or suicide-related safety signals were reported [6][12] - The majority of patients were deemed ready for discharge within 90 minutes post-dose, indicating a potential fit within existing interventional psychiatry treatment paradigms [6][12] Study Details - The Phase 2b study was conducted at 38 sites across six countries, enrolling a total of 193 patients with moderate-to-severe TRD [5][6] - It is noted as the largest controlled clinical study to investigate mebufotenin, with a low drop-out rate of 90% [6][12] - Follow-up in the open-label extension stage is ongoing, with data expected in the third quarter of 2025 [11][12] Future Plans - atai and Beckley Psytech plan to engage with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 trial design for TRD [3][12] - The strategic combination is expected to progress to shareholder approval stage following the positive Phase 2b results [4][6]