– National Ataxia Foundation (NAF) Drug Development Collaborative to cultivate resources that facilitate research and development of new potential treatments for Ataxia, a set of severe and debilitating neurodegenerative diseases
– Biohaven Pharmaceuticals, the first industry sponsor of the Collaborative, is currently conducting a Phase 3 clinical trial of troriluzole for Spinocerebellar Ataxia (SCA)
– NAF is a membership-supported non-profit organization dedicated to providing programs and services for Ataxia families, supporting Ataxia research and the search for a cure
NEW HAVEN, Conn., Nov. 11, 2020 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases including spinocerebellar ataxia, today announced its partnership with the National Ataxia Foundation (NAF) to help the nonprofit organization launch the NAF Drug Development Collaborative. As the first pharmaceutical industry member to commit support, Biohaven’s partnership will help NAF accelerate the development of new treatments for Ataxia.
Melissa Wolfe Beiner, M.D., Director of Research and Development and Clinical Lead for the Ataxia program at Biohaven, commented, “Biohaven is extremely pleased to be the first industry partner to join this important consortium. We are deeply committed to the Ataxia community, as demonstrated by our longstanding partnership with NAF and leading neurologists in the ataxia field from around the world. Together with NAF and our industry peers, we will foster a collaborative environment in which scientists, physicians, and patient advocates can come together to advance novel treatments for people suffering from these debilitating neurodegenerative disorders.”
With its launch officially announced on November 5, the NAF Drug Development Collaborative will assemble members of the pharmaceutical industry around the common goal of accelerating the development of new treatments for Ataxia, a group of progressive neurodegenerative diseases for which no specific treatment or cure is available. The industry consortium will apply its collective expertise to harness shared opportunities and tackle challenges of drug development through initiatives such as natural history and biosample data collection, development of biomarkers, validation of disease rating scales, refinement of clinical trial design, exploration of patient-reported outcomes and other data critical to the development and approval of safe and effective therapies.
Andrew Rosen, NAF Executive Director, stated, “Biohaven has been a true partner to NAF throughout their therapy development process. They have been so willing to share insights with us, and in turn, we have done everything we can to provide communications channels to our members and help recruit patients for their clinical trials. As the first member of the NAF Drug Development Collaborative, Biohaven has once again shown their leadership in the Ataxia space.”
Biohaven is currently enrolling participants in a Phase 3 clinical trial assessing the efficacy and safety of troriluzole in Spinocerebellar Ataxia at 21 sites across the United States. More information about Biohaven’s clinical trial in SCA patients can be found at www.clinicaltrials.gov [NCT03701399] and at https://www.scatrial.org/.
About Spinocerebellar Ataxia (SCA)
Hereditary Spinocerebellar Ataxias are potentially fatal, rare and severely debilitating neurodegenerative disorders affecting the cerebellum. They are characterized clinically by progressive ataxia symptoms, including difficulties with balance, speech, and coordination, and are attributed to various autosomal dominant genetic mutations. There are currently no FDA-approved treatments and no cure for SCA.
Troriluzole is a new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Troriluzole is thought to normalize synaptic glutamate levels, which are deregulated in a range of neurological and neuropsychiatric diseases. Troriluzole is believed to increase cycling of glutamate by increasing expression and function of excitatory amino acid transporters (i.e., EAAT2) located on glial cells and 2) decreasing presynaptic glutamate release. More information about troriluzole can be found at the Biohaven’s website www.biohavenpharma.com/science-pipeline/glutamate/troriluzole.
Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for spinocerebellar ataxia, obsessive-compulsive disorder and Alzheimer’s disease; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.
About the National Ataxia Foundation (NAF)
NAF is a nonprofit organization established in 1957 to help persons with Ataxia and their families. The Foundation’s primary purpose is to support Ataxia research, provide vital programs and services for Ataxia families, and help in the search for a cure. NAF is the only organization in the United States dedicated to the disease that serves all types of Ataxia. NAF works closely with the world’s leading Ataxia researchers, promoting exchanges of ideas and innovation in Ataxia discovery.
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 “believe”, “continue”, “may”, “will” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven’s management about troriluzole as a possible treatment for Spinocerebellar Ataxia, statements about expected study enrollments and completions, and expected future regulatory filings and approvals. Factors that could affect these forward-looking statements include those related to: Biohaven’s ability to effectively develop troriluzole, complying with applicable U.S. regulatory requirements, 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, the potential commercialization of Biohaven’s product candidates, the potential for Biohaven’s product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven’s product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of Biohaven’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 26, 2020, and Biohaven’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the Securities and Exchange Commission on November 9, 2020. The forward-looking statements are made as of this date 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.
Dr. Vlad Coric
Chief Executive Officer
NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.