Bright Minds' BMB-101 phase 2 shows seizure declines

Executive Summary

• Bright Minds Biosciences announced positive top-line results from its Phase 2 clinical trial of BMB-101, a selective 5-HT2C biased agonist, in adult patients with drug-resistant Absence seizures and Developmental and Encephalopathic Epilepsies (DEE).
• The study met its primary efficacy endpoints in both cohorts, demonstrating significant seizure reduction and a favorable safety profile.
• The company has initiated preparations for global registrational trials for both conditions and announced a new study in Prader-Willi Syndrome (PWS) anticipated to begin in Q1 2026.

Key Details

• Absence Seizure Cohort (n=11 evaluable):
  • 73.1% median reduction in the number of Absence seizures lasting ≥3 seconds (p=0.012).
  • 74.4% median reduction in total time in seizures lasting ≥3 seconds (seizure burden) (p=0.012).
  • Mean 90% increase in REM sleep (from 56.2 minutes to 106.7 minutes) with no change in total sleep duration.
• DEE Cohort (n=6 evaluable):
  • 63.3% median reduction in major motor seizures.
  • Subgroup analysis showed a 60.3% median reduction in Lennox-Gastaut Syndrome (LGS) patients and 76.1% in other DEE patients (Dravet and Rett syndrome).
• Study Design & Population:
  • Open-label, multicentre study with 24 patients enrolled (15 Absence, 9 DEE), exceeding the target of 20.
  • Mean age of 30 years; participants had failed a median of 3.7 treatments (Absence) and 9.8 treatments (DEE).
  • Study structure included a 4-week baseline, 4-week titration, and maintenance period (2 weeks for Absence, 4 weeks for DEE).
• Safety and Tolerability:
  • Generally well-tolerated; most treatment-emergent adverse events (TEAEs) were mild (79.6%) or moderate (17.2%).
  • No treatment-related serious adverse events (SAEs).
  • Most common AEs (≥10%): respiratory infections (20.8%), fatigue (16.7%), constipation (16.7%), headache (12.5%), drowsiness (12.5%).
  • Discontinuations occurred in 6 patients total (3 in Absence, 3 in DEE) due to reasons including taste intolerance, flu-like symptoms, dizziness, behavioral fluctuations, lethargy, and an unrelated shoulder fracture.
• Next Steps:
  • Preparations initiated for global registrational trials in Absence seizures and DEE.
  • Additional long-term data to be presented throughout the year.
  • New study in Prader-Willi Syndrome (PWS) program anticipated to begin in Q1 2026.

Notable Quotes

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