Bright Minds Biosciences Inc. (NASDAQ / CSE: DRUG) has announced the initiation of a Phase 2 clinical trial for BMB-101, a novel compound aimed at treating drug-resistant epilepsies. The company will host a Key Opinion Leader (KOL) event on September 25th to discuss the details of the BREAKTHROUGH clinical trial. The event will feature epilepsy experts who will provide insights into the unmet needs in epilepsy treatment and the potential of new therapeutic approaches.
Addressing Unmet Needs in Epilepsy Treatment
The KOL event will include presentations from Dr. Dennis Dlugos, Dr. Joe Sullivan, and Dr. Jo Sourbron, all recognized experts in epilepsy research and treatment. These thought leaders will explore the evolving landscape of drug-resistant seizures and highlight the scientific innovations driving the Phase 2 BREAKTHROUGH clinical trial design. Their insights will be crucial in understanding the potential of novel treatments like BMB-101.
BMB-101: A Novel Approach to Epilepsy Treatment
BMB-101 is a first-in-class 5-HT2C agonist in clinical studies, designed to exclusively target therapeutic pathways via G-protein signaling without causing receptor desensitization. This biased agonism at the 5-HT2C receptor adds a layer of functional selectivity within a well-validated target. The drug works exclusively through the Gq-protein signaling pathway, avoiding beta-arrestin activation, which is crucial for minimizing the risk of receptor desensitization and tolerance development. Preclinical studies have demonstrated BMB-101's efficacy in animal models of Dravet Syndrome and various models of generalized seizures.
Phase 1 Clinical Trial Results
In Phase 1 clinical studies, BMB-101 was administered to 64 healthy volunteers in Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and food-effects studies. The drug was shown to be safe and well-tolerated at all doses, with no Serious Adverse Events (SAEs) observed. Adverse Events (AEs) were mild and consistent with on-target effects for serotonergic drugs. Target engagement studies using fluid biomarkers (transient prolactin release) and physical biomarkers (Quantitative Electroencephalogram, qEEG) confirmed robust central target engagement. The qEEG signature observed was typical for anti-epileptic drugs, with a selective depression of EEG power at frequencies observed during epileptic seizures. Furthermore, a potentiation of frontal gamma-power was observed, potentially indicating improved cognition.
About Bright Minds Biosciences
Bright Minds Biosciences is focused on developing innovative treatments for neurological and psychiatric disorders. Their pipeline includes novel compounds targeting key receptors in the brain to address conditions with high unmet medical need, including epilepsy, depression, and other CNS disorders. The company's unique platform of highly selective serotonergic agonists provides a rich portfolio of NCE programs within neurology and psychiatry.
