Bright Minds Biosciences announced the initiation of Phase 2 clinical trial of BMB-101 in a group of drug-resistant epilepsies and will discuss the details of the BREAKTHROUGH clinical trial on September 25th.
The event will feature Epilepsy KOLs to discuss the unmet needs for epilepsy treatment.
BMB-101 is the first 5-HT2C agonist in clinical studies designed to exclusively target therapeutic pathways (via G-protein) without receptor desensitization.
NEW YORK, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (NASDAQ / CSE: DRUG) announces the Key Opinion Leader (KOL) event with leading experts in epilepsy research and treatment. The event will include Dr. Dennis Dlugos, Dr. Joe Sullivan, and Dr. Jo Sourbron, who will provide critical insights into the evolving landscape of drug-resistant seizures and the unmet needs in epilepsy care. These thought leaders will explore the scientific innovations driving the Phase 2 BREAKTHROUGH clinical trial design announced last week and highlight the potential for novel treatments.
Featured KOL speakers
Dr. Dennis J. Dlugos, MD, MSCE, is a professor of neurology and pediatrics at Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania School of Medicine. He is the Director of the Section of Clinical Neurophysiology and the Epilepsy/Clinical Neurophysiology Fellowship. He holds the Tristram C. Colket, Jr. Endowed Chair in Pediatric Neurology.
Dr. Dlugos is a member of the American Academy of Pediatrics, the American Academy of Neurology, the American Epilepsy Society, the American Clinical Neurophysiology Society, and the Child Neurology Society. Dr. Dlugos is a frequent lecturer locally and at national medical meetings on topics related to pediatric neurology, epilepsy, and electroencephalograms. He has published papers in journals such as Neurology, Epilepsia, Archives of Neurology, Pediatric Neurology, and Journal of Child Neurology.
Dr. Joseph Sullivan, a pediatric neurologist, serves as director of the UCSF Pediatric Epilepsy Center, where he specializes in evaluating and caring for children with epilepsy, particularly refractory epilepsy (in which medications fail to control seizures). He has special interests in Dravet syndrome and PCDH19-related epilepsy (two genetic forms of the condition) as well as evaluating children for epilepsy surgery.
Dr. Sullivan is a member of the American Epilepsy Society and serves on boards for several organizations. His roles include chair of the PCDH19 Alliance's scientific advisory board, member of the Epilepsy Foundation of Northern California's board of directors, and member of the Dravet Syndrome Foundation's medical advisory board and board of directors.
Dr. Jo Sourbron, MD, PhD, MPharm, is a physician scientist with a clinical practice at the University Hospitals of Ghent (UZ Ghent, Belgium) and a postdoctoral researcher at the University of Leuven (UZ/KU Leuven, Belgium).
Dr. Sourbron has a special interest in genetic forms of epilepsy and clinical trials for drug-resistant forms of epilepsy. He has been a preclinical researcher for over a decade, focused on finding novel serotonergic (5-HT) compounds for drug-resistant epilepsies. Dr. Sourbron has explored the efficacy and safety of a variety of anti epileptic drugs including, 5-HT2 agonists like fenfluramine and lorcaserin in various animal models.
For the past five years, he has been particularly involved in research involving epilepsy with eyelid myoclonia (EEM) with prominent photic induction (Sunflower syndrome). Concomitantly, he was involved in the pilot clinical trial of fenfluramine in Sunflower syndrome patients. Finally, he participated in several other clinical trials for drug-resistant epilepsies, such as cannabidiol in the treatment of drug-resistant epileptic disorders.
IMPORTANT INFORMATION:
Registration Details: Advance registration is required to participate in the webcast. If you cannot join live, a replay will be available. Register at Livestorm.
Q&A Instructions: To ask a question during the live Q&A session, please submit your request through the portal below the webcast player when you register or send an email to [email protected].
About BMB-101
BMB-101 is a novel scaffold 5-HT2C Gq-protein biased agonist developed using structure-based drug design. It was explicitly designed for chronic treatment of neurological disorders where tolerance and drug resistance are common issues. Biased agonism at the 5-HT2C receptor is one of its key features and adds another layer of functional selectivity within a well-validated target. BMB-101 works exclusively via the Gq-protein signaling pathway and avoids beta-arrestin activation, which is crucial to minimize the risk of receptor desensitization and tolerance development. This provides a novel mechanism, anti-epileptic drug designed to provide sustained seizure relief in hard-to-treat patient populations. In preclinical studies, BMB-101 has demonstrated efficacy in animal models of Dravet Syndrome and numerous models of generalized seizures.
In Phase 1 clinical studies, BMB-101 was given to 64 healthy volunteers in a Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and food-effects study. 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.
An extensive target-engagement study was conducted using both fluid biomarkers (transient prolactin release) and physical biomarkers (Quantitative Electroencephalogram, qEEG). Both methods confirmed robust central target engagement. A qEEG signature typical for anti-epileptic drugs was observed, with a selective depression of EEG power at frequencies observed during epileptic seizures. Furthermore, a potentiation of frontal gamma-power was observed in this study which could indicate the potential for improved cognition.
About Bright Minds Biosciences Bright Minds Biosciences is a biotechnology company developing innovative treatments for patients with neurological and psychiatric disorders. Our 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. Bright Minds is focused on delivering breakthrough therapies that can transform patients' lives.
Bright Minds Biosciences has developed a unique platform of highly selective serotonergic agonists exhibiting selectivity at different serotonergic receptors. This has provided a rich portfolio of NCE programs within neurology and psychiatry.
Forward-Looking Statements
This news release contains “forward-looking information”. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include design, progress, and completion of the BREAKTHROUGH Study, future clinical development of BMB-101, and future intended use or therapeutic benefit of BMB-101 to treat refractory epilepsy disorders. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this news release. These factors include the company’s financial position and operational runway, regulatory risk to operating in the pharmaceutical industry, and inaccuracies related to the assumption made by management relating to general availability of resources required to operate the studies noted in this news release. Additional risk factors can also be found in the Company’s public filings under the Company’s SEDAR+ profile at www.sedarplus.ca. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances, management’s estimates or opinions should change, except as required by securities legislation. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements.
The Canadian Securities Exchange has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release.
Contact Information
Alex Vasilkevich Chief Operating Officer Bright Minds Biosciences Inc. Phone: (414)7316422 Email: [email protected] Website: www.brightmindsbio.com
