Bright Minds Biosciences and Firefly Neuroscience to Collaborate Post-BREAKTHROUGH Study: Phase 2 Trial of BMB-101 in Epilepsy for EEG Data Analysis

NEW YORK AND VANCOUVER, British Columbia, Oct. 21, 2024 — Bright Minds Biosciences Inc. (Bright Minds), a biotechnology firm focused on developing innovative therapies for neurological and neuropsychiatric disorders, has announced a renewed collaboration with Firefly Neuroscience, Inc. (Firefly). Firefly is an Artificial Intelligence (AI) company that specializes in improving brain health outcomes for patients with neurological and mental disorders. The partnership will focus on providing an extensive analysis of the electroencephalogram (EEG) data for Bright Minds’ BREAKTHROUGH study, an open-label Phase 2 clinical trial. This trial evaluates the safety, tolerability, and efficacy of BMB-101, a highly selective 5-HT2C receptor agonist, in adult patients with Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).

Previously, Bright Minds and Firefly have successfully collaborated on analyzing data from the Phase 1 study of BMB-101 using Firefly’s advanced FDA-cleared BNA™ technology platform. The BREAKTHROUGH study is structured as a basket clinical trial, enrolling patients diagnosed with either Absence Epilepsy (with or without Eyelid Myoclonia) or DEE. This group of disorders includes several rare epilepsy conditions, such as Jeavons Syndrome, characterized by refractory seizures often resistant to current treatments. The study aims to enroll 20 adult participants between 18 and 65 years old.

Ian McDonald, Chief Executive Officer of Bright Minds Biosciences, expressed optimism about the collaboration, emphasizing the potential of BMB-101. He highlighted that the compound could significantly impact both the DEE and Absence Epilepsy communities and has broader applications for the 30% of epilepsy patients who experience drug resistance.

BMB-101 is a novel 5-HT2C Gq-protein biased agonist developed through structure-based drug design. It is specifically designed for chronic treatment of neurological disorders where tolerance and drug resistance are common. Its biased agonism at the 5-HT2C receptor provides functional selectivity within a well-validated target. BMB-101 works solely through the Gq-protein signaling pathway, avoiding beta-arrestin activation, which is crucial to minimize receptor desensitization and tolerance development. This novel mechanism offers a promising anti-epileptic drug aimed at providing sustained seizure relief for hard-to-treat patient populations. Preclinical studies have shown BMB-101's efficacy in animal models of Dravet Syndrome and various generalized seizure models.

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 results demonstrated that BMB-101 was safe and well tolerated at all doses, with no Serious Adverse Events (SAEs) and only mild Adverse Events (AEs) typical of serotonergic drugs. A comprehensive target-engagement study using fluid biomarkers (transient prolactin release) and physical biomarkers (Quantitative Electroencephalogram, qEEG) confirmed robust central target engagement. The qEEG signature typical for anti-epileptic drugs was observed, showing selective depression of EEG power at frequencies seen during epileptic seizures. Additionally, potentiation of frontal gamma-power was noted, suggesting potential cognitive improvements.

Bright Minds Biosciences is a biotechnology company dedicated to developing transformative treatments for neurological and psychiatric disorders. Its pipeline includes novel compounds targeting key brain receptors to address conditions with high unmet medical need, such as epilepsy, depression, and other CNS disorders. The company is committed to delivering breakthrough therapies that can significantly impact patients' lives.

Firefly is an AI company focused on developing innovative solutions to enhance brain health outcomes for patients with neurological and mental disorders. Its FDA-cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Firefly has developed a comprehensive database of brain wave tests, securing patent protection and achieving FDA clearance. The company is now launching BNA™ commercially, targeting pharmaceutical companies involved in drug research and clinical trials, as well as medical practitioners for clinical use.

Brain Network Analytics was created using artificial intelligence and machine learning on Firefly’s extensive proprietary database of high-definition longitudinal EEGs of over 17,000 patients representing various disorders, as well as clinically normal individuals. BNA™, combined with an FDA-cleared EEG system, provides clinicians with comprehensive insights into brain function, enhancing the ability to diagnose mental and cognitive disorders and optimize patient outcomes.