AtaiBeckley advances BPL-003 toward Phase 3 After Strong Phase 2 Data topline data i

Proactive - Interviews for investors

AtaiBeckley NV CEO Dr Srinivas Rao joined Steve Darling from Proactive to discuss the company’s official launch following the completion of the merger between Atai Life Sciences and Beckley Psytech, forming a new clinical-stage biopharmaceutical company focused on developing transformative treatments for mental health disorders. Rao said the combined company, now known as AtaiBeckley, brings together complementary expertise, proprietary technologies, and a robust clinical pipeline aimed at addressing treatment-resistant depression (TRD) and other mental health conditions. AtaiBeckley’s lead program, BPL-003, a short-acting psychedelic compound, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for TRD. The company expects to meet with the FDA in the coming months to finalize Phase 3 trial plans, with pivotal studies anticipated to begin in Q2 2026. The company also reported positive topline results from the open-label extension (OLE) of its Phase 2b clinical trial of BPL-003 in TRD patients. A 12 mg dose administered eight weeks after an initial dose (0.3 mg, 8 mg, or 12 mg) produced rapid, robust, and sustained antidepressant effects lasting up to eight weeks. The Phase 2b trial consisted of an eight-week, quadruple-masked, dose-finding study followed by an eight-week OLE phase. Of the 126 patients who completed the core study, 107 entered the OLE. Patients who initially received 0.3 mg recorded a mean reduction in MADRS score of 14 points by Day 57.Those who received 8 mg or 12 mg demonstrated a mean reduction of 19 points, with a 63% responder rate and a 48% remission rate at Day 57. The safety and tolerability profile of BPL-003 in the OLE remained consistent with prior studies and comparable to other compounds within the psychedelic class. Beyond BPL-003, AtaiBeckley’s pipeline includes VLS-01 (DMT buccal film) – in a Phase 2 trial for treatment-resistant depression, EMP-01 (R-MDMA) – in a Phase 2a trial for social anxiety disorder and a portfolio of preclinical 5-HT2A receptor agonists, including non-hallucinogenic neuroplastogens Rao said the newly merged entity is strategically positioned to become a leader in next-generation neuropsychiatric innovation, leveraging scientific depth and clinical momentum to bring novel treatments to patients with few or no existing options. #proactiveinvestors #ataibeckley #nasdaq #atai #clinicaltrial #bpl003 #depression #AtaiBeckley #BPL003 #PsychedelicTherapy #ClinicalTrials #MentalHealthInnovation #Phase2Results #5MeODMT #BiotechNews #DrugDevelopment #ProactiveInvestors