Bright Minds Biosciences begins Phase 2 trial of BMB-101 in epilepsy disorders

Bright Minds Biosciences initiated the BREAKTHROUGH Study, an open-label Phase 2 clinical trial 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 -. The BREAKTHROUGH study is designed as a basket clinical trial that will include patients diagnosed with either Absence Epilepsy or a DEE. This group of disorders consists of a range of rare epilepsy disorders characterized by refractory seizures that are often resistant to current treatments. The study’s objectives are to assess the safety, tolerability and efficacy of BMB-101. The primary efficacy endpoints are to evaluate the change in frequency of generalized spike-wave discharges on 24-hour electroencephalogram in participants with Absence Epilepsy and the change in seizure frequency on a daily seizure diary in participants with a DEE compared to the baseline period.