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Investing.com --Bright Minds Biosciences(NASDAQ:DRUG) stock rose 5% after the clinical-stage biotechnology company announced positive topline results from its Phase 2 BREAKTHROUGH trial for BMB-101 in patients with epilepsy-related conditions.
The company reported that BMB-101, its selective 5-HT2C biased agonist, demonstrated significant anti-seizure benefits in both study cohorts. Patients with absence seizures showed a 73.1% median reduction in seizures lasting three seconds or longer (p=0.012), while those with developmental and encephalopathic epilepsies (DEE) experienced a 63.3% median reduction in major motor seizures.
The trial, which enrolled 24 patients across both cohorts, exceeded its original target of 20 participants. Patients in the study had previously failed numerous anti-seizure treatments, with DEE patients having failed a mean of 9.8 prior treatments, highlighting the treatment-resistant nature of the study population.
Beyond seizure reduction, the drug showed a notable effect on sleep patterns, with patients in the absence seizure cohort experiencing a mean 90% increase in REM sleep without changes in total sleep duration. This improvement could be significant as REM sleep plays an important role in memory consolidation and cognitive function.
The company reported that BMB-101 was generally well-tolerated, with most treatment-emergent adverse events being mild (79.6%) or moderate (17.2%). Common side effects included respiratory infections (20.8%), fatigue (16.7%), and constipation (16.7%), with no treatment-related serious adverse events reported.
Following these positive results, Bright Minds has initiated preparations for global registrational trials in both DEE and absence seizure patients. The company also plans to begin a study in Prader Willi Syndrome in the first quarter of 2026.
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