Atai Life Sciences, Beckley Psytech report positive Phase 2b results of BPL-003

atai Life Sciences (ATAI) and Beckley Psytech, a private clinical-stage biopharmaceutical company pioneering the next generation of mental health treatments, announced positive topline results from the eight-week core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 in patients with treatment-resistant depression. The study achieved its primary endpoint as well as all key secondary endpoints. At Day 29, a single 12 mg dose of BPL-003 demonstrated a statistically significant reduction in depressive symptoms, with a mean decrease of 11.1 MADRS points from baseline vs. a 5.8 point reduction in the 0.3 mg comparator group. For the key secondary efficacy endpoints, a single 8 mg dose of BPL-003 also showed significant improvement at Day 29, with a mean MADRS score reduction of 12.1 points. Both the 8mg and 12mg doses of BPL-003 showed statistically significant improvements in MADRS scores as early as one day after dosing, with effects generally maintained out to Week 8. Safety and efficacy results from this study support the selection of the 8 mg dose of BPL-003 for advancement into Phase 3 clinical studies. atai and Beckley Psytech plan to engage with the FDA and other applicable agencies regarding the Phase 3 trial design for patients with treatment-resistant depression in the coming months. With these positive Phase 2b results, the pre-agreed success criteria for the proposed strategic combination between atai and Beckley Psytech, announced in June 2025, has been achieved and the strategic combination is now expected to progress to atai shareholder approval stage. The Phase 2b clinical study was conducted at 38 sites across six countries and enrolled a total of 193 patients with moderate-to-severe TRD. BPL-003 was generally well-tolerated at all doses. More than 99% of treatment-emergent adverse events were mild or moderate and there were no drug-related serious adverse events. These findings suggest a favourable tolerability profile which are consistent with earlier Phase 1 and Phase 2a studies of BPL-003, as well as other psychedelic studies within the class. Data from the OLE study is expected in Q3 2025 and will provide additional insights into the safety and tolerability of repeat dosing, as well as the durability of BPL-003’s antidepressant effect.