Bright Minds Biosciences (US:DRUG) Globenewswire·2026-01-06 12:16Core Insights - Bright Minds Biosciences announced positive topline results from its Phase 2 BREAKTHROUGH clinical trial for BMB-101, showing significant efficacy in reducing seizures in patients with drug-resistant Absence Seizures and Developmental and Encephalopathic Epilepsies [1] Study Overview - The Phase 2 study was an open-label, multicenter trial that evaluated the safety, tolerability, and efficacy of BMB-101 in adults, enrolling 24 patients, surpassing the target of 20 [2] - The study included a 4-week baseline period followed by a 4-week titration and maintenance period [2] Patient Profile - The study enrolled 24 patients, with 15 having Absence Seizures and 9 with DEE, with a mean age of 30 years [3] - Patients had a median of 3 concomitant anti-seizure treatments in the Absence cohort and 5 in the DEE cohort, having previously failed up to 16 treatments [3] Efficacy Results - BMB-101 demonstrated a 73.1% median reduction in Absence Seizures lasting ≥3 seconds (p = 0.012) and a 63.3% median reduction in major motor seizures in the DEE cohort [6][15] - The study also reported a 90% increase in REM sleep duration in patients with Absence Seizures, with no change in total sleep duration [11] Safety and Tolerability - BMB-101 was generally well tolerated, with 79.6% of treatment-emergent adverse events being mild and 17.2% moderate, with no serious treatment-related adverse events reported [10] - The most common adverse events included respiratory infections (20.8%), fatigue (16.7%), and constipation (16.7%) [10] Next Steps - Bright Minds has initiated preparations for global registrational trials in both Absence Seizures and DEE, with additional data on long-term outcomes expected throughout the year [12] - The company plans to initiate a study in Prader Willi Syndrome in Q1 2026 [12]