Biohaven Initiates Pivotal Trial of Novel Investigational Drug for Treatment of Migraine
Biohaven (NYSE: BHVN) has initiated a pivotal Phase 2 trial evaluating BHV-2100 for the acute treatment of migraine. BHV-2100 is a potential first-in-class, orally administered Transient Receptor Potential Melastatin-3 (TRPM3) antagonist, a novel and non-opioid investigational treatment for migraine and other pain disorders.
The trial is a randomized, double-blind, placebo-controlled study assessing the efficacy and safety of two doses (75 mg and 150 mg) of BHV-2100. It will enroll approximately 575 patients across 60 sites in the United States. The study aims to support registration with FDA-accepted coprimary endpoints of pain freedom and freedom from most bothersome symptom at 2 hours.
BHV-2100 demonstrated excellent safety and tolerability in Phase 1 trials, with rapid absorption and sustained concentrations. Biohaven aims to address the unmet needs of migraine patients, including those who do not respond to existing therapies, estimated to be about one-third of the 40 million patients in the US.
Biohaven (NYSE: BHVN) ha avviato un importante trial di Fase 2 per valutare BHV-2100 nel trattamento acuto dell'emicrania. BHV-2100 è un potenziale farmaco innovativo di prima classe, somministrato per via orale, che agisce come antagonista del Recettore Potenziale Transitorio Melastatin-3 (TRPM3), un nuovo trattamento sperimentale non oppioide per l'emicrania e altri disturbi del dolore.
Lo studio è un trial randomizzato, in doppio cieco e controllato con placebo che valuta l'efficacia e la sicurezza di due dosi (75 mg e 150 mg) di BHV-2100. Saranno arruolati circa 575 pazienti in 60 centri negli Stati Uniti. L'obiettivo dello studio è di supportare la registrazione con la FDA, con punti di fine co-primari accettati di liberazione dal dolore e liberazione dal sintomo più fastidioso dopo 2 ore.
BHV-2100 ha dimostrato un'eccellente sicurezza e tollerabilità nelle prove di Fase 1, con un'assorbimento rapido e concentrazioni sostenute. Biohaven mira a soddisfare i bisogni insoddisfatti dei pazienti emicranici, compresi quelli che non rispondono alle terapie esistenti, stimati in circa un terzo dei 40 milioni di pazienti negli Stati Uniti.
Biohaven (NYSE: BHVN) ha iniciado un ensayo clínico de Fase 2 para evaluar BHV-2100 en el tratamiento agudo de la migraña. BHV-2100 es un potencial medicamento de primera clase, administrado por vía oral, que actúa como antagonista del Receptor Potencial Transitorio Melastatina-3 (TRPM3), un novedoso tratamiento en investigación no opioide para la migraña y otros trastornos del dolor.
El ensayo es un estudio randomizado, doble ciego y controlado con placebo que evalúa la eficacia y seguridad de dos dosis (75 mg y 150 mg) de BHV-2100. Se inscribirán aproximadamente 575 pacientes en 60 sitios en los Estados Unidos. El estudio tiene como objetivo apoyar el registro con la FDA utilizando puntos finales co-principales aceptados de libertad del dolor y libertad del síntoma más molesto a las 2 horas.
BHV-2100 demostró una excelente seguridad y tolerabilidad en los ensayos de Fase 1, con una rápida absorción y concentraciones sostenidas. Biohaven busca abordar las necesidades no satisfechas de los pacientes con migraña, incluidos aquellos que no responden a las terapias existentes, que se estima que representan aproximadamente un tercio de los 40 millones de pacientes en EE. UU.
Biohaven (NYSE: BHVN) 는 편두통의 급성 치료를 위한 BHV-2100에 대한 중요한 2상 시험을 시작했습니다. BHV-2100은 경구로 투여되는 일시적 수용체 잠재적 멜라스타틴-3(TRPM3) 길항제로서, 편두통 및 기타 통증 장애에 대한 새로운 비-opioid 연구 치료제입니다.
이번 시험은 두 가지 용량(75 mg 및 150 mg)의 BHV-2100의 효능과 안전성을 평가하는 무작위 이중 맹검 위약 대조 연구입니다. 미국 내 60개 기관에서 약 575명의 환자를 등록할 예정입니다. 이 연구는 FDA 등록을 지원하는 것을 목표로 하며, 2시간 후에 가장 성가신 증상에서의 자유와 통증에서의 자유를 주요 종결점으로 설정합니다.
BHV-2100은 1상 시험에서 우수한 안전성과 내약성을 보여줬으며, 빠른 흡수와 지속적인 농도를 발휘했습니다. Biohaven은 기존 요법에 반응하지 않는 약 4000만 미국 환자 중 약 3분의 1을 차지하는 편두통 환자들의 해결되지 않은 필요를 충족하는 것을 목표로 하고 있습니다.
Biohaven (NYSE: BHVN) a lancé un essai clinique de Phase 2 pour évaluer BHV-2100 dans le traitement aigu de la migraine. BHV-2100 est un potentiel médicament d'une nouvelle classe, administré par voie orale, agissant comme un antagoniste du Récepteur Potentiel Transitoire Melastatin-3 (TRPM3), un traitement expérimental novateur et non opioïde pour la migraine et d'autres troubles de la douleur.
L'essai est une étude randomisée, en double aveugle et contrôlée par placebo évaluant l'efficacité et la sécurité de deux doses (75 mg et 150 mg) de BHV-2100. Environ 575 patients seront inclus dans 60 sites aux États-Unis. L'objectif de l'étude est de soutenir l'enregistrement auprès de la FDA avec des points finaux co-primaires acceptés de liberté de douleur et de liberté du symptôme le plus gênant après 2 heures.
BHV-2100 a montré une excellente sécurité et tolérabilité lors des essais de Phase 1, avec une absorption rapide et des concentrations soutenues. Biohaven vise à répondre aux besoins non satisfaits des patients migraineux, y compris ceux qui ne réagissent pas aux thérapies existantes, estimés à environ un tiers des 40 millions de patients aux États-Unis.
Biohaven (NYSE: BHVN) hat eine entscheidende Phase-2-Studie zur Bewertung von BHV-2100 für die akute Behandlung von Migräne initiiert. BHV-2100 ist ein potenzieller erstmals im Einsatz befindlicher, oral verabreichter Transient Receptor Potential Melastatin-3 (TRPM3) Antagonist, eine neuartige und nicht-opioide experimentelle Behandlung für Migräne und andere Schmerzstörungen.
Die Studie ist eine randomisierte, placebo-kontrollierte Doppelblindstudie, die die Wirksamkeit und Sicherheit von zwei Dosen (75 mg und 150 mg) von BHV-2100 bewertet. Es werden etwa 575 Patienten an 60 Standorten in den Vereinigten Staaten eingeschlossen. Die Studie zielt darauf ab, die Registrierung bei der FDA mit akzeptierten primären Endpunkten von Schmerzfreiheit und Freiheit vom am meisten lästigen Symptom nach 2 Stunden zu unterstützen.
BHV-2100 zeigte in Phase-1-Studien eine hervorragende Sicherheit und Verträglichkeit mit schneller Absorption und nachhaltigen Konzentrationen. Biohaven zielt darauf ab, die unbefriedigten Bedürfnisse von Migränepatienten zu adressieren, einschließlich derjenigen, die nicht auf bestehende Therapien ansprechen, was schätzungsweise ein Drittel der 40 Millionen Patienten in den USA ausmacht.
- Initiation of pivotal Phase 2 trial for BHV-2100, a potential first-in-class migraine treatment
- BHV-2100 demonstrated excellent safety and tolerability in Phase 1 trials
- Rapid absorption and sustained concentrations of BHV-2100 observed in Phase 1 trials
- Large target market of 40 million migraine patients in the US, with potential to address unmet needs
- None.
Insights
The initiation of a pivotal Phase 2 trial for BHV-2100, a novel TRPM3 antagonist, in acute migraine treatment is a significant development for Biohaven. This study could potentially lead to a first-in-class therapy, addressing an unmet need in migraine treatment. Key points to consider:
- The trial design, with 575 patients across 60 US sites, is robust and aims to support FDA registration.
- BHV-2100 showed promising safety and pharmacokinetic profiles in Phase 1, with rapid absorption and sustained efficacious levels.
- If successful, this could diversify Biohaven's migraine portfolio and potentially capture a share of the 40 million US migraine patient market.
However, investors should note that Phase 2 trials still carry significant risks and success is not guaranteed. The timeline for potential commercialization, if successful, would likely be several years away.
This news represents a positive development for Biohaven, potentially expanding its pipeline in the lucrative migraine market. Key financial implications include:
- Increased R&D expenses in the near term to fund the Phase 2 trial.
- Potential for significant future revenue if BHV-2100 reaches the market, given the large patient population and unmet needs in migraine treatment.
- Enhanced company valuation if the trial shows positive results, as it would demonstrate Biohaven's ability to develop novel therapies beyond its existing portfolio.
Investors should monitor trial progress closely, as positive data could be a catalyst for stock price appreciation. However, it's important to balance this potential upside against the inherent risks of drug development and the time horizon for potential commercialization.
- Biohaven initiated a pivotal Phase 2 trial evaluating BHV-2100 in the acute treatment of migraine
- BHV-2100 is a potential first-in-class, potent, orally administered Transient Receptor Potential Melastatin-3 (TRPM3) antagonist— a novel, highly selective, and non-opioid investigational treatment being developed for migraine and other pain disorders
- Despite recent treatment advances, migraine remains a leading cause of disability and burden, impacting 40 million people in the US and 1 billion world-wide
Richard B. Lipton, M.D., the Edwin S. Lowe Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine, and Director of the Montefiore Headache Center commented, "The burden of migraine remains high, and many patients experience inadequate relief or suffer from tolerability issues from existing therapies. There remains a need for novel treatments for migraine to lessen disease burden and disability. The TRPM3 ion channel has been implicated in the pathophysiology of migraine, and this trial is the first to assess efficacy and tolerability of a novel agent targeting this mechanism in migraine."
The pivotal Phase 2 study is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of two doses (75 mg and 150 mg) of BHV-2100 in the acute treatment of migraine. The trial is designed to support registration with FDA-accepted coprimary endpoints of pain freedom and freedom from most bothersome symptom at 2 hours. The trial will enroll approximately 575 patients across 60 sites in
Beth Emerson, M.D., M.B.A., Executive Medical Director and Development Lead for Migraine at Biohaven, stated "Biohaven remains extremely committed to advancing novel therapeutic options for people suffering from migraine. Building on our deep passion, unparalleled expertise, and successful track record of developing innovative medications that are currently making a difference for migraine patients today, our team is thrilled to embark on this important program to potentially deliver a new, cutting-edge therapy for migraine. This includes a large number of patients who do not respond to existing therapies, estimated to be approximately one-third of the 40 million patients in the US who desperately need more treatment options."
BHV-2100 is a potentially first-in-class, potent, selective, orally administered TRPM3 antagonist— a novel, non-sedating non-opioid treatment for migraine and pain. BHV-2100 demonstrated excellent safety and tolerability across all doses tested in Phase 1 trials in healthy adults, without the thermoregulatory adverse events observed with other TRP antagonists or sedation associated with other pain medications. Additionally, the pharmacokinetic profile is very well-suited for use in the treatment of acute migraine. Single doses of BHV-2100 demonstrated rapid absorption and sustained concentrations above predicted efficacious levels at all doses tested after 20 minutes with maximal drug concentrations achieved at approximately 1.5 to 2 hours and a half-life of approximately 8-12 hours.
Beth Morris, Vice President of Biohaven Clinical Operations, added "Biohaven has deep expertise in running clinical trials in migraine and this study will assess an important new potential therapy for patients. I am proud of our clinical operations team for efficiently advancing this trial into Phase 2 after completing the initial Phase 1 trial earlier this year. Days matter for patients and if this study is positive, we will be one step closer to delivering another novel treatment option to better meet the needs of people with migraine: to resolve symptoms and to return to their lives quickly."
About Biohaven
Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA (spinocerebellar ataxia); myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer. For more information, visit www.biohaven.com.
Forward-looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; the potential for Biohaven's product candidates to be first-in-class therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741
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SOURCE Biohaven Ltd.
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