NEW HAVEN, CT—(Marketwired – July 20, 2016) – Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven” or the “Company”) reported today that the Company has begun dosing subjects in its first clinical trial to evaluate the safety and pharmacokinetics of BHV–4157. Biohaven recently received clearance from the FDA on its IND and permission to begin dosing in humans.
This initial clinical trial will evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of BHV–4157. BHV–4157 is a new chemical entity (NCE) that modulates glutamate, one of the most important neurotransmitters in the brain that is present in more than 90% of all brain synapses. Agents that modulate glutamate neurotransmission may have therapeutic potential in multiple disease states involving glutamate dysfunction, including ALS, Alzheimer's disease, Rett syndrome, dementia, dystonia, tinnitus, and affective disorders like major depressive disorder and anxiety disorders.
Dr. Vlad Coric, M.D., Chief Executive Officer at Biohaven, commented, “Reaching this step in the clinical development process is a very exciting moment for Biohaven and brings us one step closer to our ultimate goal of testing BHV–4157 for efficacy in patent populations. Our first dosing in this pharmacokinetic study represents the culmination of many years of chemistry discovery work and preclinical studies that are required to safely begin dosing a NCE in clinical trials. We continue to remain on track to begin our phase III registrational trial in SCA in the coming months.”
In May, 2016, the U.S. Food and Drug Administration (FDA) granted the company's orphan drug designation request covering BHV–4157 for the treatment of spinocerebellar ataxia (SCA). SCA is a rare, debilitating neurodegenerative disorder. Standard of care treatment is supportive and no medications are currently approved for this debilitating condition.
“We are very pleased to begin the development of this important product candidate. This study will explore a broad range of doses, and results will directly inform dosing in our upcoming randomized controlled trial of BHV–4157 in patients with SCA,” stated Dr. Robert Berman, M.D., Chief Medical Officer at Biohaven.
About Biohaven
Biohaven is a privately–held biopharmaceutical company engaged in the identification and development of clinical stage compounds targeting the glutamatergic system and other neurological pathways. Biohaven has licensed intellectual property from Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Biohaven is owned by a group of investors including Portage Biotech Inc. (OTC PINK: PTGEF) (CNSX: PBT.U), Yale University, and other private investors. The Company's first drug candidate, BHV–0223, is a novel formulation of a glutamate–modulating agent, being developed under FDA 505(b)(2) guidelines. The FDA cleared the Company's IND for BHV–0223 in August 2015, and Biohaven has completed a pharmacokinetic study in humans and is planning to launch a pivotal bioequivalence study by 4Q2016. Biohaven's second clinical compound, BHV–4157, is a New Molecular Entity (NCE) for neurodegenerative diseases, neuropsychiatric disorders and potentially cancer indications. The Company plans to advance other glutamatergic approaches and is actively exploring licenses for additional compounds. Further information regarding Biohaven can be found at: http://biohavenpharma.com
About Orphan Drug Designation
The FDA, through its Office of Orphan Products Development (OOPD), grants orphan status to drugs and biologic products that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides a drug developer with certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication. Further information regarding Orphan Drug Designation can be found at: http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm
Forward–Looking Statements
This news release includes forward–looking statements within the meaning of the U.S. federal and Canadian securities laws. These forward–looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward–looking statements. The use of certain words, including the words “estimate,” “project,” “intend,” “expect,” “believe,” “anticipate,” “will,” “plan,” “could,” “may” and similar expressions are intended to identify forward–looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward–looking statements and you should not place undue reliance on the Company's forward–looking statements. 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 including receipt of regulatory approvals and market conditions. The forward–looking statements are made as of this date and the Company does not undertake any obligation to update any forward–looking statements, whether as a result of new information, future events or otherwise.