-Approximately 40 million people in the U.S. suffer from migraine and there has been minimal improvement in standard of care acute treatment of migraine since the 1990s
-Rimegepant is an oral calcitonin gene-related peptide (CGRP) antagonist being developed for the acute and preventive treatment of migraine
-Results published in the New England Journal of Medicine demonstrate that, compared to placebo, a single-dose oral rimegepant provides superior, rapid freedom from pain and associated symptoms of migraine within two hours
NEW HAVEN, Conn., July 10, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN), announced today that positive results from a Phase 3 pivotal clinical trial of rimegepant, Biohaven's small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine, are published in the July 12, 2019 issue of the New England Journal of Medicine (NEJM). These data show that, compared to placebo, patients treated with a single dose of oral rimegepant 75mg experienced superior, rapid pain freedom and freedom from the most bothersome migraine-associated symptom.
"The results from this study demonstrate rimegepant's potential as an effective treatment for migraine, a widespread, disabling disease that has seen only minimal improvements in acute treatment since the 1990s," said Richard B. Lipton, M.D., Lead Author, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Center, and Chair of Biohaven's CGRP Scientific Advisory Board. "I hope the publication of these data in the New England Journal of Medicine, a journal with worldwide reach and significance, will bring attention to this complex neurological condition and the need for new treatment options."
In this pivotal Phase 3 trial of rimegepant, 1,186 patients were randomized to receive a single dose of either rimegepant or placebo. A broad spectrum of clinically meaningful benefit compared to placebo was seen across multiple outcome measures, including the co-primary endpoints of pain freedom and freedom from the most bothersome symptom at two hours post-dosing.
A single dose of rimegepant 75mg was demonstrated to have significant superiority on pain freedom and pain relief at 2 hours, freedom from the most bothersome symptom at 2 hours as well as photophobia and phonophobia at 2 hours. Additionally, rimegepant was numerically superior in terms of sustained pain freedom and pain relief through 48 hours and the ability to return to function at 2 hours.
Rimegepant was generally well tolerated with a low incidence of side effects. The most frequent adverse events were nausea, occurring in 1.8% of rimegepant patients, as compared to 1.1% of patients on placebo and urinary tract infection (UTI), occurring in 1.5% of rimegepant patients, as compared to 1.1% of patients on placebo. Serious adverse events were observed in one patient in the rimegepant group (back pain) and two patients in the placebo group (Chest Pain and UTI). Additionally, rimegepant demonstrated a liver safety profile similar to placebo in this acute treatment trial.
"Publication in this prestigious journal allows us to share the positive data from this pivotal Phase 3 trial of rimegepant with the broader scientific community. These results are representative of the consistent benefit of rimegepant in migraine we have seen across our entire clinical program," said Vlad Coric, M.D., CEO of Biohaven. "As we previously guided, we submitted a New Drug Application with the U.S. Food and Drug Administration in the second quarter of this year and are looking forward to working with the Agency to advance this new candidate drug for acute treatment to the millions of people suffering from migraine in the U.S."
Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in all three Phase 3 trials are consistent with regulatory guidance from the FDA and provide the basis for the NDA submission to the FDA.
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, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the effectiveness and safety of rimegepant, the expected timing, commencement and outcomes of the Company'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 the Company's product candidates and the potential for the Company's product candidates to be first in class or best in class therapies. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify 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. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019 and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, filed with the Securities and Exchange Commission on May 8, 2019. 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, except as required by law.
For further information, contact:
Dr. Vlad Coric
Chief Executive Officer
Sam Brown Inc.
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