Bright Minds Reports Phase 2 BREAKTHROUGH Trial Results For BMB‑101 In Drug‑Resistant Absence Seizures And Developmental Epilepsies, Meeting Primary Endpoints With Robust Seizure Reduction And Favorable Safety

• BMB-101 demonstrated significant anti-seizure benefit in both cohorts with favorable safety and tolerability
  • Absence: 73.1% median reduction in the number of absence seizure ≥3s, p = 0.012
  • DEE: 63.3% median reduction in major motor seizures
• REM sleep improvement in patients with Absence Seizures: mean 90% increase in REM sleep with no change in total sleep duration
• Company has initiated preparations for global registrational trials in both DEE and Absence Seizure patients
• Bright Minds to hold conference call and live webcast at 8AM ET today

NEW YORK, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) ("Bright Minds" or the "Company"), a clinical-stage biotechnology company focused on developing highly selective 5-HT receptor agonists for neurological and psychiatric disorders, today announced positive and significant topline results from its Phase 2 BREAKTHROUGH clinical trial evaluating BMB-101, a selective 5-HT2C biased agonist, in adult patients with drug-resistant Absence Seizures and Developmental and Encephalopathic Epilepsies. The study met its primary efficacy endpoints in both cohorts, demonstrating robust seizure reduction with a favorable safety and tolerability profile.

Phase 2 BREAKTHROUGH Study Overview

The Phase 2 open-label, multicenter study evaluated safety, tolerability and efficacy of BMB-101 in adults with drug-resistant Absence Seizures and DEE. A total of 24 patients were enrolled, exceeding the original target of 20. The study included a 4-week baseline, 4-week titration and maintenance period (2 weeks for Absence cohort, 4 weeks for DEE cohort).

Primary Endpoints:

• Absence cohort: change from baseline in the number of Absence Seizures (lasting ≥3s) on 24h EEG, conducted by independent and blinded reviewers
• DEE cohort: change from baseline in major motor seizure frequency (seizure diary)

Next Steps

Bright Minds Biosciences has initiated preparations for global registrational trials in Absence Seizures and DEE. Additional data including long-term outcomes will be presented throughout the year. Bright Minds Biosciences will also be initiating a study in Prader Willi Syndrome, currently anticipated to begin in Q1 2026 ("PWS Program").