NEW YORK, NY — January 6, 2026 — Leads & Copy — Bright Minds Biosciences Inc. (CSE: DRUG) (Nasdaq: DRUG) has announced positive topline results from its Phase 2 BREAKTHROUGH clinical trial, which evaluated BMB-101 in adult patients with drug-resistant Absence Seizures and Developmental and Encephalopathic Epilepsies (DEE). The study demonstrated robust seizure reduction with a favorable safety and tolerability profile, meeting its primary efficacy endpoints in both cohorts.
The Phase 2 open-label, multicenter study assessed the safety, tolerability, and efficacy of BMB-101, a selective 5-HT2C biased agonist. A total of 24 patients were enrolled, surpassing the initial target of 20. The study included a 4-week baseline, a 4-week titration, and a maintenance period (2 weeks for the Absence cohort, 4 weeks for the DEE cohort).
In the Absence cohort (n=11), patients experienced a 73.1% median reduction in the number of absence seizures lasting ≥3 seconds (p = 0.012). Additionally, there was a 74.4% median reduction in total time in seizures lasting ≥3 seconds during a 24-hour period (p = 0.012). The DEE cohort (n=6), which included patients with Lennox-Gastaut Syndrome (LGS), Dravet syndrome, and Rett syndrome, showed a 63.3% median reduction in major motor seizures. Specifically, LGS patients had a 60.3% median reduction, while other DEE patients had a 76.1% reduction.
BMB-101 was generally well-tolerated. Most treatment-emergent adverse events were mild (79.6%) or moderate (17.2%), with no treatment-related serious adverse events. Common adverse events (≥10%) included respiratory infections (20.8%), fatigue (16.7%), constipation (16.7%), headache (12.5%), and drowsiness (12.5%).
Beyond seizure control, the study also explored the effects of BMB-101 on sleep. Patients experienced a 90% increase in REM sleep (from 56.2 minutes at baseline to 106.7 minutes on BMB-101), while overall sleep duration remained unchanged. 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. The company also plans to initiate a study in Prader Willi Syndrome (PWS) in Q1 2026.
The Bright Minds virtual event will be webcast live by visiting the “Investors” section of the Company’s website and selecting “Events and Presentations.”
BMB-101 is a novel scaffold 5-HT2C Gq-protein biased agonist designed for chronic treatment of neurological disorders. Preclinical studies have shown efficacy in animal models of epilepsy, binge eating, aggression, substance use disorder, and cognitive decline.
In Phase 1 clinical studies, BMB-101 was demonstrated to be safe and well tolerated at all doses. No Serious Adverse Events (SAEs) were observed, and Adverse Events (AEs) were mild in nature and in line with on-target effects for serotonergic drugs.
Bright Minds is a biotechnology company focused on developing treatments for neurological and psychiatric disorders. Its pipeline includes compounds targeting key receptors in the brain to address conditions such as epilepsy, PWS, and depression.
Contact Information:
Alex Vasilkevich
Chief Operating Officer
Bright Minds Biosciences Inc.
T: 414-731-6422
E: alex@brightmindsbio.com
Investor Relations
Lisa M. Wilson
T: 212-452-2793
E: lwilson@insitecony.com
Source: Bright Minds Biosciences
