BioShin enrolls first patient into an Asia-Pacific regional multi-center phase III clinical trial of rimegepant (BHV-3000) for the acute treatment of migraine.
SHANGHAI, China, Nov. 23, 2020 (GLOBE NEWSWIRE) -- BioShin Limited announced today that the first patients were enrolled in its regional multi-center study, BHV3000-310, being conducted in China and Korea. BHV3000-310 is a double-blind, randomized trial evaluating the safety and efficacy of rimegepant in the acute treatment of migraine. Karl Lintel, M.D., Chief Executive Officer of BioShin commented, “We are very pleased to have started enrollment in study BHV300-310. Rimegepant was launched in March 2020 in the USA where its differentiated profile with a rapid onset of action and long-half life is being recognized by patients and providers as an important new treatment option for people suffering with migraine. There has been a lack of innovative treatment for more than two decades for the acute treatment of migraine, and we believe that rimegepant will meet the unmet medical needs of migraine patients in the Asia-Pacific region, as it is doing in the USA.""Migraine is a common and serious disease that affects human health," said Professor Yu Shengyuan, Chief of Neurology at the PLA General Hospital. “According to the results of the World Health Organization (WHO) 2013 Global Burden of Disease Survey published in The Lancet, migraine is the third most common human disease and the first cause of disability in under 50s, and we need new, effective and safe treatment options to help improve the lives of our patients. I believe that rimegepant will be a welcome treatment option for patients and I am encouraged that we are moving one step closer to bringing rimegepant to patients in Asia with the start of study BHV3000-310.”Professor Byung-kun Kim, investigator at the Nowon Eulji Medical Center in Korea announced, "We are very happy that Nowon Eulji Center has enrolled the first subjects in the BHV 3000-310 study, and we expect that the results of this study will bring new hope to migraine patients suffering with migraine.”About Migraine Migraine is a chronic and debilitating disorder characterized by recurrent attacks lasting four to 72 hours with multiple symptoms, including typically one-sided, pulsating headaches of moderate or severe pain intensity that are associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). Migraine affects approximately 9% of the adult population in China, comprising 80 TO 90 million adults. The total indirect cost to Chinese society from lost productivity is estimated to be about USD$40 billion. Comorbid conditions associated with migraine include depression, anxiety and cardiovascular disease.About BHV-3000 (Rimegepant) Rimegepant (Nurtec™ ODT) is a calcitonin gene-related peptide (CGRP) receptor antagonist that is being developed for acute migraine treatment. Rimegepant was approved by the US FDA for the acute treatment of migraine in February 2020, and an sNDA has been accepted by the US FDA for the preventive treatment of migraine. The CGRP receptor is located within pain-signaling pathways, intracranial arteries and mast cells and its activation is thought to play a causal role in migraine pathophysiology. Treatment with a CGRP receptor antagonist is believed to relieve migraine through the possible mechanisms of 1) blocking neurogenic inflammation, 2) decreasing artery dilation, and 3) inhibiting pain transmission. This new approach to the treatment of migraine avoids the cardiovascular effects produced by active vasoconstriction associated with the current standard triptan therapy (non-selective 5-HTlB/lD agonists (e.g., sumatriptan [Imitrex™]).About the BHV3000-310 study The BHV3000-310 study is an Asia-Pacific multicenter Phase III clinical study. It is a double-blind, randomized, placebo-controlled, safety and efficacy trial of BHV-3000 (rimegepant) for the treatment of migraine in the acute phase. The study obtained a CTA from China’s NMPA on March 20, 2020, and the IND from the Korean FDA on Jun 29, 2020.About BioShinBioShin Limited, a privately held biopharmaceutical company with offices in Shanghai, is advancing the Biohaven clinical portfolio in the Asia-Pacific region. BioShin holds rights to the Biohaven portfolio for all of the Asia-Pacific Region, including Australia and New Zealand, excluding Japan. BioShin’s neuroinnovation portfolio includes the US 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 obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase inhibition for multiple system atrophy and amyotrophic lateral sclerosis.Biohaven (NYSE: BHVN) is a majority shareholder in BioShin. More information about BioShin is available at www.bioshin.comAbout BiohavenBiohaven Pharmaceutical Holding Company Ltd (Biohaven) is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers and ALS Biopharma LLC and. Our progress is fueled by an entrepreneurial organizational structure and an impressive range of experience in drug development along with the confident support of top-tier biopharma investors. Biohaven's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at www.biohavenpharma.comForward-Looking Statements This 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 the potential use of Biohaven's CGRP receptor antagonists as a treatment for patients with plaque psoriasis. Factors that could affect these forward-looking statements include those related to: Biohaven's ability to effectively develop a CGRP receptor antagonist for the treatment of plaque psoriasis, 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.NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC. Karl Lintel CEO, BioShin Karl.Lintel@bioshin.com Media Contact: CHINA - Zoey Wang General Manager, BioShin Zoey.Wang@bioshin.com
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