Bright Minds reports positive Phase 2 results for epilepsy drug

Bright Minds Biosciences said its Phase 2 BREAKTHROUGH trial of BMB-101 met primary efficacy endpoints, reporting median reductions of 73.1% in absence seizures and 63.3% in major motor seizures in DEE. The article mentions the company was valued at $588.45 million, that it is preparing global registrational trials, and that a Prader‑Willi study is planned for Q1 2026.

Bright Minds Biosciences announced that its Phase 2 BREAKTHROUGH trial of BMB-101 met primary efficacy endpoints in patients with drug-resistant epilepsy. The study was an open-label, multicenter trial with a 4-week baseline period followed by titration and maintenance. The trial enrolled 24 patients across two cohorts and included patients with a mean age of 30 years who had previously failed multiple anti-seizure treatments. The article mentions the company was valued at $588.45 million and that it is preparing registrational trials and a Prader‑Willi study planned for the first quarter of 2026. Key findings: - The trial reported a 73.1% median reduction in absence seizures lasting three seconds or longer in one cohort (p=0.012). - The study reported a 63.3% median reduction in major motor seizures in patients with Developmental and Epileptic Encephalopathies (DEE). - The study enrolled 24 patients; 18 completed the maintenance period and six discontinued during early treatment. - Participants had previously failed multiple anti-seizure therapies, with averages of 3.7 prior treatments in the absence cohort and 9.8 in the DEE cohort. - BMB-101, described as a selective 5-HT2C biased agonist, was associated with a 90% increase in REM sleep while overall sleep duration remained similar. - Safety was reported as generally well tolerated; most treatment-emergent adverse events were mild (79.6%) or moderate (17.2%), with respiratory infections (20.8%), fatigue (16.7%), and constipation (16.7%) among the more common events. The article mentions planned presentations of the results via a conference call and webcast and notes analyst commentary and ratings referenced in the report. Summary: The company reports these Phase 2 results as supporting further development of BMB-101 and has initiated preparations for global registrational trials while planning a Prader‑Willi study in early 2026. A conference call and webcast were scheduled to present the data; broader regulatory timelines and specific trial dates were not detailed.