Biohaven Presents at Migraine Trust International Symposium and Highlights Positive Results from Study 301 and Study 302 of Rimegepant, an Oral CGRP Receptor Antagonist, in the Acute Treatment of Migraine
- Both pivotal Phase 3 trials show single-dose rimegepant provides rapid and lasting relief from pain and associated symptoms of migraine
- Phase 1 pharmacokinetic study also demonstrates bioequivalence of rimegepant fast-dissolve Zydis® orally dissolving tablet (ODT) with oral tablet formulation used in Study 301 and Study 302
NEW HAVEN, Conn., Sept. 6, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) is presenting data from two randomized, pivotal Phase 3 clinical trials of rimegepant, a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, and a Phase 1 study of rimegepant ODT at the 17th Biennial Migraine Trust International Symposium (MTIS). These Phase 3 data support rimegepant's potential to provide patients with rapid and sustained pain freedom and freedom from the most bothersome migraine-associated symptom (MBS) in the acute treatment of migraine using a single 75mg dose.
"The data from these two pivotal Phase 3 trials show the potential of rimegepant as a much needed, new option for the acute treatment of migraine," said Richard B. Lipton, M.D., 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. "Additionally, the Phase 1 study of rimegepant ODT shows this new convenient formulation has the potential to provide faster relief, which could be an important benefit for patients with migraine."
In the two completed Phase 3 trials of rimegepant, 1,162 and 1,186 patients were randomized to receive a single dose of either rimegepant or placebo in Study 301 and Study 302, respectively. A full spectrum of clinically meaningful benefits compared to placebo were seen across multiple outcome measures. These included the co-primary endpoints of pain freedom and freedom from the MBS at two hours post-dose as well as pain relief and freedom from functional disability at two hours post-dose. These gains were durable, with rimegepant outperforming placebo in terms of sustained pain freedom, pain relief, freedom from the MBS, and freedom from functional disability from 2 to 48 hours. In addition, patients receiving rimegepant were less likely to use rescue medication compared to patients in the placebo group. Rimegepant was generally well tolerated, with the most frequent adverse event, nausea, occurring in only 1.4% of rimegepant patients, as compared to 1.1% of patients on placebo across both studies. The overall safety of rimegepant was similar to placebo on tests of liver function.
"We are pleased to present the results from our positive Phase 3 pivotal trials at MTIS," said Vlad Coric, M.D., CEO of Biohaven. "The studies illustrate the breadth of benefits that rimegepant may provide to patients suffering with migraine. We have started the work required to broaden the geographic footprint of rimegepant's development program and look forward to when we can provide rimegepant to patients globally."
Biohaven will also present data from a Phase 1 study which demonstrates the bioequivalence of rimegepant ODT with the oral tablet formulation. Results show that the fast-dissolve Zydis® formulation has a favorable pharmacokinetic profile that might translate into an earlier onset of action.
This is the first time the data from these rimegepant studies have been presented at a European scientific meeting.
Details on these studies can be found here: http://biohavenpharma.com/mtis2018/
MTIS2018-171: Rimegepant 75 mg, an oral calcitonin gene-related peptide antagonist, for the acute treatment of migraine: two Phase 3, double-blind, randomized, placebo-controlled trials
MTIS2018-170: A Phase 1 study to evaluate the bioequivalence of oral tablet and orally dissolving tablet formulations of rimegepant, a small molecule CGRP receptor antagonist
The clinical trials were sponsored by Biohaven, which may benefit financially from the results. Dr. Lipton is a paid consultant and a shareholder of Biohaven.
Rimegepant is Biohaven's orally-dosed 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 consistently established across three randomized controlled trials to date: the two completed pivotal Phase 3 trials, and a previously reported Phase 2b trial. The co-primary endpoints achieved in the two Phase 3 trials are consistent with regulatory guidance from the U.S. Food and Drug Administration (FDA) and provide the basis for a planned submission of a new drug application (NDA) to the FDA in 2019.
Approximately 110 million Europeans and over 36 million Americans suffer from migraine. Acute attacks of migraine can differ in intensity and frequency, with many being highly disabling. More than 90 percent of migraine sufferers are unable to work or function normally during an attack. In the Global Burden of Disease Study, updated in 2015, migraine was ranked as the seventh highest cause worldwide of years lost due to disability. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class specific to the acute treatment of migraine in over 25 years. This unique and specific mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases, or who either do not respond or have inadequate or inconsistent response to triptans or are intolerant to them.
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, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulation platforms. 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.com.
Zydis is a registered trademark of R.P. Scherer Technologies, Inc.
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, including statements about rimegepant's potentially favorable cardiovascular profile, rimegepant's potential to be an improved, effective and safe treatment option for the acute treatment of migraine and prevention of migraine, rimegepant's potential benefits as compared to triptans and the current standard of care, the potential benefits of the ODT formulation of rimegepant, the potential market for rimegepant and the Company's expected timelines for submissions to regulatory authorities, are forward-looking statements. The use of certain words, including "potential" and "will" and similar expressions, is intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives 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 those described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2018 and other filings Biohaven makes with the U.S. Securities and Exchange Commission from time to time. 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, the Chief Executive Officer, Biohaven at Vlad.Coric@biohavenpharma.com
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