Bright Minds Biosciences and Firefly Neuroscience to Collaborate After the BREAKTHROUGH Study: A Phase 2 Trial of BMB-101 in Absence Epilepsy and Developmental Epileptic Encephalopathy for Full Analysis of EEG Data
Bright Minds Biosciences (NASDAQ: DRUG) has announced a renewed collaboration with Firefly Neuroscience (NASDAQ: AIFF) for the analysis of EEG data from the BREAKTHROUGH study, a Phase 2 clinical trial of BMB-101. This open-label trial is evaluating the safety, tolerability, and efficacy of BMB-101, a selective 5-HT2C receptor agonist, in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
The study is designed as a basket clinical trial, targeting enrollment of 20 adult participants aged 18-65. It aims to address rare epilepsy disorders characterized by refractory seizures resistant to current treatments. Bright Minds believes BMB-101 has the potential to be a best-in-class 5-HT2C agonist with broad applicability across 30% of epilepsy patients experiencing drug resistance.
Bright Minds Biosciences (NASDAQ: DRUG) ha annunciato una collaborazione rinnovata con Firefly Neuroscience (NASDAQ: AIFF) per l'analisi dei dati EEG dello studio BREAKTHROUGH, una sperimentazione clinica di fase 2 di BMB-101. Questo studio in aperto valuta la sicurezza, la tollerabilità e l'efficacia di BMB-101, un agonista selettivo del recettore 5-HT2C, in pazienti adulti con epilessia assente classica e encefalopatia epilettica sviluppo (DEE).
Lo studio è progettato come uno studio clinico basket, con l'obiettivo di arruolare 20 partecipanti adulti di età compresa tra 18 e 65 anni. Mira ad affrontare disturbi epilettici rari caratterizzati da crisi refrattarie resistenti ai trattamenti attuali. Bright Minds crede che BMB-101 abbia il potenziale per essere un agonista 5-HT2C di classe superiore con una vasta applicabilità in oltre il 30% dei pazienti epilettici che presentano resistenza ai farmaci.
Bright Minds Biosciences (NASDAQ: DRUG) ha anunciado una colaboración renovada con Firefly Neuroscience (NASDAQ: AIFF) para el análisis de datos de EEG del estudio BREAKTHROUGH, un ensayo clínico de fase 2 de BMB-101. Este ensayo abierto está evaluando la seguridad, tolerabilidad y eficacia de BMB-101, un agonista selectivo del receptor 5-HT2C, en pacientes adultos con epilepsia ausencia clásica y encefalopatía epileptica del desarrollo (DEE).
El estudio está diseñado como un ensayo clínico tipo cesta, con el objetivo de inscribir a 20 participantes adultos de entre 18 y 65 años. Su propósito es abordar trastornos epilépticos raros caracterizados por convulsiones refractarias resistentes a los tratamientos actuales. Bright Minds cree que BMB-101 tiene el potencial de ser un agonista 5-HT2C de primera clase con amplia aplicabilidad en el 30% de los pacientes epilépticos que experimentan resistencia a los medicamentos.
Bright Minds Biosciences (NASDAQ: DRUG)는 BMB-101의 2상 임상 시험인 BREAKTHROUGH 연구의 EEG 데이터 분석을 위해 Firefly Neuroscience (NASDAQ: AIFF)와의 협력 재개를 발표했습니다. 이 공개 라벨 시험은 5-HT2C 수용체의 선택적 작용제인 BMB-101의 성인 환자에 대한 안전성, 내약성 및 효능을 평가하고 있습니다. 고전적인 결석형 간질 및 발달성 간질 뇌병증 (DEE)을 앓고 있는 환자들입니다.
이 연구는 18세에서 65세 사이의 성인 참가자 20명을 모집하는 것을 목표로 하는 바스켓 임상 시험으로 설계되었습니다. 현재 치료에 저항하는 난치성 발작으로 특징 지어지는 희귀한 간질 장애를 다루는 것을 목표로 하고 있습니다. Bright Minds는 BMB-101이 약물 내성을 겪고 있는 간질 환자의 30%에서 광범위한 적용 가능성을 가진 최고급 5-HT2C 작용제가 될 수 있는 잠재력을 가지고 있다고 믿고 있습니다.
Bright Minds Biosciences (NASDAQ: DRUG) a annoncé une collaboration renouvelée avec Firefly Neuroscience (NASDAQ: AIFF) pour l'analyse des données EEG de l'étude BREAKTHROUGH, un essai clinique de phase 2 portant sur BMB-101. Cet essai en ouvert évalue la sécurité, la tolérabilité et l'efficacité de BMB-101, un agoniste sélectif des récepteurs 5-HT2C, chez des patients adultes souffrant de l'épilepsie d'absence classique et d'encéphalopathie épileptique développementale (DEE).
L'étude est conçue comme un essai clinique de type panier, visant à recruter 20 participants adultes âgés de 18 à 65 ans. Elle a pour objectif de traiter des troubles épileptiques rares caractérisés par des crises réfractaires aux traitements actuels. Bright Minds estime que BMB-101 a le potentiel d'être un agoniste 5-HT2C de premier ordre avec une large applicabilité chez 30 % des patients épileptiques présentant une résistance médicamenteuse.
Bright Minds Biosciences (NASDAQ: DRUG) hat eine erneute Zusammenarbeit mit Firefly Neuroscience (NASDAQ: AIFF) zur Analyse von EEG-Daten der BREAKTHROUGH-Studie bekannt gegeben, einer Phase-2-Studie zu BMB-101. Diese offene Studie bewertet die Sicherheit, Verträglichkeit und Wirksamkeit von BMB-101, einem selektiven 5-HT2C-Rezeptor-Agonisten, bei erwachsenen Patienten mit klassischer Absenzenepilepsie und entwicklungsbedingter epileptischer Enzephalopathie (DEE).
Die Studie ist als Basket-Studie konzipiert, die eine Rekrutierung von 20 erwachsenen Teilnehmern im Alter von 18 bis 65 Jahren anstrebt. Sie soll seltene Epilepsiestörungen ansprechen, die durch refraktäre Anfälle gekennzeichnet sind, die auf aktuelle Behandlungen nicht ansprechen. Bright Minds glaubt, dass BMB-101 das Potenzial hat, ein best-in-class 5-HT2C-Agonist zu sein, der bei 30% der Epilepsiepatienten mit Arzneimittelresistenz breit anwendbar ist.
- Collaboration with Firefly Neuroscience for advanced AI analysis of EEG data
- Phase 2 clinical trial (BREAKTHROUGH study) of BMB-101 in progress
- Potential for BMB-101 to be a best-in-class 5-HT2C agonist
- Addressing rare epilepsy disorders resistant to current treatments
- Broad applicability of BMB-101 across 30% of drug-resistant epilepsy patients
- None.
Insights
The collaboration between Bright Minds Biosciences and Firefly Neuroscience for the BREAKTHROUGH study represents a significant step in epilepsy research. The use of Firefly's FDA-cleared BNA™ technology platform to analyze EEG data from the Phase 2 trial of BMB-101 could provide important insights into the drug's efficacy and mechanism of action.
Key points to consider:
- BMB-101 is a highly selective 5-HT2C receptor agonist, targeting a specific neurotransmitter system implicated in epilepsy.
- The study focuses on rare and difficult-to-treat forms of epilepsy, including Absence Epilepsy and Developmental Epileptic Encephalopathy.
- The basket trial design allows for evaluation across multiple related disorders, potentially broadening the drug's application.
- If successful, BMB-101 could address the unmet need in drug-resistant epilepsy, which affects approximately
30% of epilepsy patients.
While the collaboration is promising, investors should note that this is still an early-stage clinical trial and the road to potential FDA approval remains long. The success of this Phase 2 trial will be critical in determining the future prospects of BMB-101 and its potential market impact.
NEW YORK AND VANCOUVER, British Columbia, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (Bright Minds or the Company) (NASDAQ: DRUG), a biotechnology company focused on developing novel therapies for neurological and neuropsychiatric disorders, today announced that it is once again collaborating with Firefly Neuroscience, Inc. (Firefly) (NASDAQ: AIFF), an Artificial Intelligence (AI) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, to provide a full analysis of the electroencephalogram (EEG) data in the Company’s 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).
Bright Minds and Firefly have previously collaborated successfully to analyze the data of the Company’s first-in-human Phase 1 study of BMB-101 using Firefly’s advanced artificial intelligence, FDA-cleared BNA™ technology platform.
The BREAKTHROUGH study is designed as a basket clinical trial that will include patients diagnosed with either Absence Epilepsy (with or without Eyelid Myoclonia) or DEE. This group of disorders consists of a range of rare epilepsy disorders, including Epilepsy with Eyelid Myoclonia (known as Jeavons Syndrome). These conditions are characterized by refractory seizures that are often resistant to current treatments. The BREAKTHROUGH study is targeting enrollment of 20 adult participants aged from 18 to 65 years old.
“After successful use of the BNA platform to analyze the data from our Phase 1 study, we look forward to once again collaborating with the Firefly team at the conclusion of our Phase 2 program for our lead compound, BMB-101, to provide valuable insights into the EEG recordings during the study,” said Ian McDonald, Chief Executive Officer of Bright Minds Biosciences. “We believe BMB-101 has the potential to be a best-in-class 5-HT2C agonist. This compound is not only poised to make a significant impact in both the DEE and Absence Epilepsy communities, but also has broad applicability across the
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-arrest in 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.
About Firefly
Firefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use.
Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly’s extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician’s ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome.
Please visit https://fireflyneuro.com/ for more information.
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 BREAKTHROUGHStudy, 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: alex@brightmindsbio.com
Website: www.brightmindsbio.com
Investor Relations
Lisa M. Wilson
T: 212-452-2793
E: lwilson@insitecony.com
FAQ
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