Bright Minds Biosciences Announces BMB‑201 Outperforms Sumatriptan in Validated Preclinical Vascular Headache Model
Bright Minds Biosciences (NASDAQ: DRUG) has announced promising preclinical results for BMB-201 in treating vascular headaches. The compound demonstrated superior performance compared to sumatriptan in a validated rat model study.
Key findings show that BMB-201 achieved statistically significant reductions in facial mechanical allodynia, with greater effect sizes than sumatriptan across multiple timepoints. In male subjects, BMB-201 showed 86% efficacy vs. sumatriptan's 81% at 1 hour, and 53-64% vs. 44% at 2 hours. In females, BMB-201 achieved 76-100% efficacy vs. sumatriptan's 56% at 1 hour, and 80% vs. 63% at 2 hours.
Bright Minds Biosciences (NASDAQ: DRUG) ha comunicato risultati preclinici promettenti per BMB-201 nel trattamento delle cefalee vascolari. Il composto ha mostrato prestazioni superiori rispetto al sumatriptan in uno studio su modello ratto validato.
I risultati principali indicano che BMB-201 ha ottenuto riduzioni statisticamente significative dell'allodinia meccanica facciale, con dimensioni dell'effetto maggiori rispetto al sumatriptan in diversi momenti temporali. Nei soggetti maschi, BMB-201 ha mostrato una efficacia dell'86% vs 81% del sumatriptan a 1 ora e 53-64% vs 44% a 2 ore. Nelle femmine, BMB-201 ha raggiunto una efficacia del 76-100% vs 56% del sumatriptan a 1 ora e 80% vs 63% a 2 ore.
Bright Minds Biosciences (NASDAQ: DRUG) ha anunciado resultados preclínicos prometedores para BMB-201 en el tratamiento de dolores de cabeza vasculares. El compuesto mostró un rendimiento superior al sumatriptán en un estudio validado en ratas.
Los hallazgos clave indican que BMB-201 logró reducciones estadísticamente significativas de la alodinia mecánica facial, con tamaños de efecto mayores que los del sumatriptán en varios puntos temporales. En machos, BMB-201 mostró una eficacia del 86% vs 81% del sumatriptán a 1 hora y 53-64% vs 44% a 2 horas. En hembras, BMB-201 alcanzó una eficacia del 76-100% vs 56% del sumatriptán a 1 hora y 80% vs 63% a 2 horas.
Bright Minds Biosciences (NASDAQ: DRUG)는 혈관성 두통 치료를 위한 BMB-201의 전임상 결과가 유망하다고 발표했습니다. 해당 화합물은 검증된 쥐 모델 연구에서 수마트립탄보다 우수한 성능을 보였습니다.
주요 결과에 따르면 BMB-201은 얼굴 기계적 통각과민(facial mechanical allodynia)을 통계적으로 유의미하게 감소시켰으며, 여러 시점에서 수마트립탄보다 더 큰 효과 크기를 보였습니다. 수컷에서는 BMB-201이 1시간에서 86% 효능 vs 수마트립탄 81%, 2시간에서 53-64% vs 44%를 나타냈습니다. 암컷에서는 1시간에 76-100% 효능 vs 수마트립탄 56%, 2시간에 80% vs 63%를 달성했습니다.
Bright Minds Biosciences (NASDAQ: DRUG) a annoncé des résultats précliniques prometteurs pour BMB-201 dans le traitement des maux de tête vasculaires. Le composé a démontré de meilleures performances que le sumatriptan dans une étude validée sur modèle de rat.
Les résultats clés montrent que BMB-201 a entraîné des réductions statistiquement significatives de l'allodynie mécanique faciale, avec des tailles d'effet supérieures à celles du sumatriptan à plusieurs moments. Chez les mâles, BMB-201 a montré une efficacité de 86% vs 81% pour le sumatriptan à 1 heure, et de 53–64% vs 44% à 2 heures. Chez les femelles, BMB-201 a atteint une efficacité de 76–100% vs 56% pour le sumatriptan à 1 heure, et de 80% vs 63% à 2 heures.
Bright Minds Biosciences (NASDAQ: DRUG) hat vielversprechende präklinische Ergebnisse für BMB-201 bei der Behandlung vaskulärer Kopfschmerzen bekanntgegeben. Die Verbindung zeigte in einem validierten Rattenmodell eine bessere Wirksamkeit als Sumatriptan.
Wichtige Ergebnisse zeigen, dass BMB-201 statistisch signifikante Reduktionen der facialen mechanischen Allodynie erzielte, mit größeren Effektstärken als Sumatriptan zu mehreren Zeitpunkten. Bei männlichen Probanden zeigte BMB-201 eine Wirkung von 86% vs. 81% bei Sumatriptan nach 1 Stunde und 53–64% vs. 44% nach 2 Stunden. Bei weiblichen Tieren erreichte BMB-201 76–100% vs. 56% bei Sumatriptan nach 1 Stunde und 80% vs. 63% nach 2 Stunden.
- None.
- Results are still in preclinical stage, requiring further clinical trials
- Potential regulatory hurdles before market approval
NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (NASDAQ: DRUG) today announced compelling preclinical results for its investigational compound BMB‑201, in a validated isosorbide dinitrate (ISDN) rat model of vascular headache. BMB-201 produced statistically significant reductions in facial mechanical allodynia across both male and female cohorts at 1 and 2 hours post-dose, compared to vehicle, and demonstrated greater effect sizes than sumatriptan at multiple timepoints.
Key Results
• Robust efficacy versus vehicle at 1 and 2 hours in both sexes (periorbital von Frey thresholds).
• Benchmark comparison: BMB‑201 showed greater effect sizes than sumatriptan at multiple timepoints and doses (e.g., males: BMB‑201
• Consistent activity across sexes and aligned with a nitric‑oxide trigger paradigm.
“BMB‑201 delivered strong and reproducible activity in a stringent vascular headache model, with efficacy signals that exceeded sumatriptan at multiple timepoints. This further validates the use of 5-HT2 agonists in pain management,” said Jan Torleif Pedersen, Chief Science Officer of Bright Minds Biosciences.
“These data, together with previously reported efficacy data from a broad range of pain models support advancing BMB‑201 toward clinical development in headache and migraine‑related conditions,” said Ian McDonald, Chief Executive Officer of Bright Minds Biosciences.
About BMB-201
BMB-201, a selective 5-HT2A/2C receptor agonist, was designed to harness the analgesic potential of serotonin modulation without the hallucinogenic effects commonly associated with 5-HT2A activation. As a prodrug of BMB-A39a, it exhibits minimal activity at the 5-HT2B receptor, ensuring a reduced risk of side effects.
About the NIH HEAL Initiative
The National Institutes of Health (NIH) Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is an NIH-wide effort to speed scientific solutions to the overdose epidemic, including opioid and stimulant use disorders, and the crisis of pain. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction and enhancing pain management. For more information, visit: https://heal.nih.gov.
About the HEAL Preclinical Screening Platform for Pain Program
The PSPP program, part of the NIH HEAL Initiative, evaluates non-opioid assets in a battery of established preclinical pain models. The PSPP program accepts small molecules, biologics, devices, or natural products for evaluation, from researchers in academia and industry worldwide. For more information, visit: Preclinical Screening Platform for Pain (PSPP) | National Institute of Neurological Disorders and Stroke.
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 studies, future clinical development of BMB-201, and its potential therapeutic benefit for migraine and other 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
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
FAQ
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