Bright Minds Biosciences Inc. (NASDAQ: DRUG) is advancing its lead compound, BMB-101, into Phase 2 clinical trials for the treatment of drug-resistant epilepsy disorders. The BREAKTHROUGH study, an open-label Phase 2 trial, is evaluating the safety, tolerability, and efficacy of BMB-101, a highly selective 5-HT2C receptor agonist, in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
Collaboration with Firefly Neuroscience
Bright Minds Biosciences is collaborating with Firefly Neuroscience (NASDAQ: AIFF) to conduct a full analysis of electroencephalogram (EEG) data from the BREAKTHROUGH study. Firefly's FDA-cleared Brain Network Analytics (BNA™) technology platform will be utilized to provide insights into the drug's efficacy and mechanism of action.
Trial Design and Endpoints
The BREAKTHROUGH study is designed as a basket clinical trial, targeting enrollment of 20 adult participants aged 18-65. The trial includes a 4-week baseline period, an 8-week (Absence epilepsy group) to 12-week (DEE group) treatment phase, and a 4-week follow-up period.
The primary efficacy endpoints include:
- Change in frequency of generalized spike-wave discharges (GSWD) on 24-hour EEG in participants with Absence Epilepsy.
- Change in seizure frequency on a daily seizure diary in participants with DEE compared to the baseline period.
An open-label extension trial lasting at least 12 months will be available for subjects who respond to BMB-101, as agreed upon by their physician.
BMB-101: A Novel Approach to Epilepsy Treatment
BMB-101 is a novel scaffold 5-HT2C Gq-protein biased agonist developed using structure-based drug design. It is designed for chronic treatment of neurological disorders where tolerance and drug resistance are common issues. In Phase 1 clinical studies, BMB-101 was shown to be safe and well-tolerated at all doses, with no serious adverse events observed.
Ian McDonald, CEO of Bright Minds Biosciences, stated, "We believe BMB-101 has the potential to be a best-in-class 5-HT2C agonist...[with] broad applicability across the 30% of all epilepsy patients who experience drug resistance."
Addressing Unmet Needs in Epilepsy
Epilepsy is a chronic neurological disorder characterized by recurrent seizures. Absence Epilepsy and DEE are rare forms of epilepsy often resistant to current treatments. Approximately 30% of epilepsy patients experience drug resistance, highlighting the need for new therapeutic options.
Bright Minds believes BMB-101 offers a differentiated treatment option for patients with refractory epilepsy and could provide a new standard of care for a wider population of epilepsy sufferers.
