Bright Minds Biosciences Announces Positive Findings from its DBA/2 Mouse Model Study Evaluating BMB-101
Bright Minds Biosciences (NASDAQ: DRUG) has announced positive results from its DBA/2 mouse model study evaluating BMB-101, its novel 5-HT2C Gq-protein biased agonist. The study demonstrated that BMB-101 completely eliminated drop attacks in the DBA/2 mouse model and achieved 100% survival rate by reversing brainstem serotonin deficits and preventing seizure-induced respiratory arrest.
The DBA/2 mouse model is particularly significant as it replicates phenomena such as tonic/clonic seizures, drop attacks, and sudden unexpected death in epilepsy (SUDEP). These findings are crucial as SUDEP is the leading cause of seizure-related premature death, especially in drug-resistant epilepsy patients. For Dravet syndrome patients, the risk of premature death is estimated at 15-20%, with over half attributed to SUDEP.
Bright Minds Biosciences (NASDAQ: DRUG) ha annunciato risultati positivi dallo studio condotto sul modello murino DBA/2 per valutare BMB-101, il suo nuovo agonista selettivo 5-HT2C Gq-protein biased. Lo studio ha dimostrato che BMB-101 ha eliminato completamente gli attacchi di caduta nel modello murino DBA/2, raggiungendo un tasso di sopravvivenza del 100% grazie alla capacità di invertire i deficit di serotonina nel tronco encefalico e prevenire l'arresto respiratorio indotto da crisi epilettiche.
Il modello murino DBA/2 è particolarmente rilevante poiché riproduce fenomeni come crisi tonico-cloniche, attacchi di caduta e morte improvvisa in epilessia (SUDEP). Questi risultati sono fondamentali poiché la SUDEP rappresenta la principale causa di morte prematura correlata alle crisi, soprattutto nei pazienti con epilessia resistente ai farmaci. Per i pazienti con sindrome di Dravet, il rischio di morte prematura è stimato tra il 15 e il 20%, con oltre la metà attribuita alla SUDEP.
Bright Minds Biosciences (NASDAQ: DRUG) ha anunciado resultados positivos de su estudio en el modelo de ratón DBA/2 para evaluar BMB-101, su novedoso agonista sesgado 5-HT2C Gq-protein. El estudio demostró que BMB-101 eliminó completamente los ataques de caída en el modelo de ratón DBA/2 y logró una tasa de supervivencia del 100% al revertir los déficits de serotonina en el tronco cerebral y prevenir el paro respiratorio inducido por convulsiones.
El modelo de ratón DBA/2 es especialmente importante porque replica fenómenos como convulsiones tónico-clónicas, ataques de caída y muerte súbita inesperada en epilepsia (SUDEP). Estos hallazgos son cruciales, ya que la SUDEP es la principal causa de muerte prematura relacionada con convulsiones, especialmente en pacientes con epilepsia resistente a medicamentos. En pacientes con síndrome de Dravet, el riesgo de muerte prematura se estima entre un 15 y un 20%, con más de la mitad atribuida a SUDEP.
Bright Minds Biosciences (NASDAQ: DRUG)는 DBA/2 마우스 모델을 이용한 BMB-101 평가 연구에서 긍정적인 결과를 발표했습니다. BMB-101은 새로운 5-HT2C Gq-단백질 바이어스 작용제입니다. 연구 결과 BMB-101이 DBA/2 마우스 모델에서 낙상 발작을 완전히 제거하고, 뇌간 세로토닌 결핍을 회복시키며 발작으로 인한 호흡 정지를 예방하여 100% 생존률을 달성했음을 보여주었습니다.
DBA/2 마우스 모델은 강직성/간대성 발작, 낙상 발작, 그리고 SUDEP(간질 환자의 갑작스러운 예기치 못한 사망)과 같은 현상을 재현한다는 점에서 중요합니다. 이러한 발견은 SUDEP가 발작 관련 조기 사망의 주요 원인임을 고려할 때 매우 중요하며, 특히 약물 저항성 간질 환자에게서 더욱 그렇습니다. Dravet 증후군 환자의 경우 조기 사망 위험은 15-20%로 추정되며, 그 중 절반 이상이 SUDEP에 기인합니다.
Bright Minds Biosciences (NASDAQ : DRUG) a annoncé des résultats positifs issus de son étude sur le modèle murin DBA/2 évaluant le BMB-101, son nouvel agoniste biaisé 5-HT2C Gq-protéine. L'étude a démontré que BMB-101 éliminait complètement les chutes dans le modèle murin DBA/2 et atteignait un taux de survie de 100 % en renversant les déficits en sérotonine du tronc cérébral et en prévenant l'arrêt respiratoire induit par les crises.
Le modèle murin DBA/2 est particulièrement important car il reproduit des phénomènes tels que les crises tonico-cloniques, les chutes et la mort subite inattendue en épilepsie (SUDEP). Ces résultats sont cruciaux car la SUDEP est la principale cause de décès prématuré lié aux crises, notamment chez les patients souffrant d’épilepsie résistante aux médicaments. Pour les patients atteints du syndrome de Dravet, le risque de décès prématuré est estimé entre 15 et 20 %, plus de la moitié étant attribuée à la SUDEP.
Bright Minds Biosciences (NASDAQ: DRUG) hat positive Ergebnisse aus seiner Studie am DBA/2-Mausmodell zur Bewertung von BMB-101, einem neuartigen 5-HT2C Gq-Protein-biased Agonisten, bekannt gegeben. Die Studie zeigte, dass BMB-101 die Abfallanfälle im DBA/2-Mausmodell vollständig eliminierte und eine Überlebensrate von 100% erreichte, indem es Serotoninmangel im Hirnstamm umkehrte und krampfinduzierten Atemstillstand verhinderte.
Das DBA/2-Mausmodell ist besonders bedeutend, da es Phänomene wie tonisch-klonische Anfälle, Abfallanfälle und plötzlichen unerwarteten Tod bei Epilepsie (SUDEP) nachbildet. Diese Ergebnisse sind entscheidend, da SUDEP die führende Ursache für vorzeitigen, an Anfällen bedingten Tod ist, insbesondere bei Patienten mit medikamentenresistenter Epilepsie. Bei Patienten mit Dravet-Syndrom wird das Risiko für einen vorzeitigen Tod auf 15-20 % geschätzt, wobei mehr als die Hälfte auf SUDEP zurückzuführen ist.
- Complete elimination of drop attacks in DBA/2 mouse model
- 100% survival rate achieved in the study
- BMB-101 showed dose-dependent efficacy
- Successfully prevented seizure-induced respiratory arrest
- None.
Insights
BMB-101 shows promise in preventing SUDEP by eliminating seizures in preclinical models, representing significant potential for treating drug-resistant epilepsy.
Bright Minds' preclinical results for BMB-101 are scientifically meaningful and potentially clinically significant. The complete elimination of drop attacks in the DBA/2 mouse model represents a critical proof-of-concept for this novel 5-HT2C agonist. This model is particularly valuable because it mimics several key aspects of human epilepsy, including tonic-clonic seizures and, most importantly, sudden unexpected death in epilepsy (SUDEP).
The 100% survival rate reported in treated animals is particularly striking. SUDEP remains one of the most devastating consequences of epilepsy, especially in populations with Dravet syndrome where the premature death risk reaches
Mechanistically, BMB-101's reported reversal of brainstem serotonin deficits suggests a targeted approach to preventing seizure-induced respiratory arrest - believed to be a primary mechanism in SUDEP. The serotonergic system is intricately involved in respiratory control, and deficits have been implicated in the pathophysiology of SUDEP.
While these preclinical results are promising, several critical questions remain about human translation: Will BMB-101 demonstrate similar efficacy across different epilepsy etiologies beyond the genetic DBA/2 model? What is its safety profile regarding other serotonergic side effects? And critically, how will the drug perform in human trials, especially given the complexity of treating Developmental and Epileptic Encephalopathies like Dravet syndrome?
These findings suggest BMB-101 could potentially address a critical gap in current epilepsy treatment paradigms - not just reducing seizure frequency but potentially preventing the most catastrophic outcome of epilepsy disorders.
- BMB-101 demonstrated a complete elimination of drop attacks in the DBA/2 mouse model -
- The DBA/2 model is highly predictive of sudden unexpected death in epilepsy (SUDEP) -
- Findings highlight BMB-101’s potential to address critical gaps in SUDEP prevention -
NEW YORK and VANCOUVER, British Columbia, May 13, 2025 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE: DRUG) (NASDAQ: DRUG) (“Bright Minds” or the “Company”), a company focused on developing highly selective 5-HT2 agonists for the treatment of drug-resistant epilepsy, depression, and other central nervous system (CNS) disorders, today announced positive findings from its DBA/2 mouse model study. BMB-101, the Company’s novel scaffold 5-HT2C Gq-protein biased agonist, demonstrated a complete elimination of drop attacks in the DBA/2 mouse model.
“DBA/2 is an excellent model for understanding the effect of anti-epileptic drugs (AEDs) on the etiology of seizures,” stated Jan Torleif Pedersen, PhD, MSc, Director, Chief Science Officer, of Bright Minds Biosciences. “BMB-101 demonstrated dose-dependent efficacy in the DBA/2 mouse model of epilepsy, and drop seizures were completely eliminated. Notably, BMB-101 achieved
The DBA/2 mouse model is an inbred mouse strain in which young DBA/2 mice are susceptible to audiogenic seizures, making them a model for epilepsy studies. This epilepsy model does re-capitulate phenomenon such as tonic/clonic seizures, drop attacks, and sudden unexpected death in epilepsy.
These findings highlight BMB-101’s potential to address critical gaps in SUDEP prevention, a leading cause of mortality in Developmental and Epileptic Encephalopathy (DEE) patients. For individuals with Dravet syndrome, the risk of premature death has been estimated as 15
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
Bright Minds 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 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, have the potential to occur, or be achieved. Forward-looking statements in this news release include BMB-101 impacting gaps in SUDEP prevention or reducing the risk of death for individuals with Dravet Syndrome, , and future intended use or therapeutic benefit of BMB-101 to treat 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, market condition, success of competitors products in respect of epilepsy treatment and timelines related to such products, regulatory risk to operating in the pharmaceutical industry, risk related to BMB-101 failing in development, not receiving required regulatory approvals, or being delayed to a point where it is not commercially viable, risk related to regulatory agencies imposing additional requirements or delay the initiation of clinical trials, or new or changing laws imposing additional requirements; clinical trials may also not demonstrate the safety or efficacy of BMB-101 in the manner needed to allow the product to go into development. It remains uncertain whether BMB-101 can be developed as a safe and effective treatment of Dravet Syndrome or other epilepsy disorders, and if so, whether the product will be commercially accepted and profitable. 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
Investor Relations
Lisa M. Wilson
T: 212-452-2793
E: lwilson@insitecony.com
Alex Vasilkevich
Chief Operating Officer
Bright Minds Biosciences Inc.
T: 414-731-6422
E: alex@brightmindsbio.com
Website: www.brightmindsbio.com
FAQ
What are the key findings of Bright Minds Biosciences (DRUG) DBA/2 mouse study for BMB-101?
How does BMB-101 address SUDEP risk in epilepsy patients?
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What is the mortality risk for Dravet syndrome patients according to DRUG's research?
