Biohaven Expands Rimegepant Development Program to Include New Prevention of Migraine Phase 3 Trial and Highlights Key Late-Breaking Presentations at American Headache Society (AHS) Annual Scientific Meeting
– Phase 3 clinical trial to evaluate rimegepant as a preventive therapy for migraine expected to begin by the fourth quarter of 2018
– Late-breaking oral presentation at AHS to present pivotal Phase 3 trial data showing single-dose rimegepant provides rapid and lasting relief from pain and associated symptoms of migraine
– Additional Phase 3 trial data show demonstrable impact of rimegepant on return to normal functioning and relief of disability from migraine throughout 48-hour period post-dosing
– Late-breaking oral presentation of preclinical study shows rimegepant and BHV-3500 lack vasoconstrictive properties in human coronary or cerebral arteries
– Late-breaking poster presentation of Phase 1 study demonstrates bioequivalence of rimegepant orally dissolving tablet (“ODT”) with oral tablet formulation
New Haven, CT June 28, 2018 — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) is presenting expanded data from two randomized, pivotal Phase 3 clinical trials of rimegepant, Biohaven’s small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, on Saturday, June 30, 2018 at the American Headache Society (AHS) Annual Scientific Meeting 2018. These data support rimegepant’s potential to provide patients with pain freedom and freedom from the most bothersome migraine-associated symptom in the acute treatment of migraine using a single dose.
“The two acute treatment Phase 3 clinical trials demonstrate that a single dose of rimegepant can relieve pain and restore function for people with 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. “Most importantly, rimegepant has the potential to help millions of people with migraine get back to work and back to their families.”
In the two completed pivotal Phase 3 trials of rimegepant, 1,162 and 1,186 patients were randomized to receive a single dose of either rimegepant or placebo. A full spectrum of clinically meaningful benefit compared to placebo was seen across multiple outcome measures. These included the co-primary endpoints of pain freedom and freedom from the most bothersome symptom at two hours post-dosing. These gains were durable, with rimegepant outperforming placebo in terms of sustained pain freedom and sustained freedom from the most bothersome symptom from 2 to 24 hours, and from 2 to 48 hours. In terms of function, rimegepant-treated patients saw meaningful gains over placebo in both pain relief and freedom from functional disability at 2 hours post-dose. These gains were also durable, with rimegepant outperforming placebo in sustained pain relief and sustained freedom from functional disability from 2 to 24 hours and 2 to 48 hours. In addition, there was a low use of rescue medications in patients treated with rimegepant.
The Phase 3 trial results showed increasing benefit in relief from migraine-associated symptoms after dosing, with a greater proportion of rimegepant patients achieving freedom from photophobia (light sensitivity), phonophobia (sound sensitivity) and nausea over eight hours as compared to placebo. 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. Additionally, rimegepant demonstrated a liver safety profile similar to placebo.
Biohaven is also presenting new data from a preclinical study of rimegepant and BHV-3500, a second small molecule product candidate from Biohaven’s CGRP receptor antagonist platform, in which no active vasoconstrictive properties with either product candidates were observed. This differentiates the two CGRP receptor antagonists from the current standard of care for the acute treatment of migraine, the triptans, which have contraindications for use by patients with cardiovascular conditions such as coronary artery disease, and warnings about use by patients with multiple cardiovascular risk factors such as hypertension and diabetes. Patients with absolute cardiovascular contraindications to triptans are currently being enrolled in Biohaven’s long-term safety study which began in 2017.
“We are excited about these positive Phase 3 trials and the consistency of benefit of rimegepant that we’ve seen across the program. These clinical results, coupled with the new preclinical data which support the potential for a favorable cardiovascular profile, highlight the potential for rimegepant to be an effective treatment for migraine, including for those who are not currently able to take the standard of care due to safety concerns,” said Vlad Coric, M.D., CEO of Biohaven. “More than 10% of the U.S. adult population suffers from migraine, yet few meaningful advancements in treatment have been made in the last 25 years. We are committed to providing new options for those who suffer from migraine with the ongoing development of rimegepant and other therapies in our novel CGRP platform.”
The Company is also presenting new data from a Phase 1 study evaluating the bioequivalence of oral tablet and ODT formulations of rimegepant. These data show that the fast-dissolve ZydisÒ formulation has a favorable pharmacokinetic profile that might translate into an earlier onset of action, an important feature for patients in pain.
Details on these rimegepant studies can be found here: http://biohavenpharma.com/ahs2018/
Title: Efficacy, Safety, and Tolerability of Rimegepant 75 mg, an Oral CGRP Receptor Antagonist, for the Acute Treatment of Migraine: Results from a Double-Blind, Randomized, Placebo-Controlled Trial, Study 302
Title: Efficacy, Safety, and Tolerability of Rimegepant 75 mg, an Oral CGRP Receptor Antagonist, for the Acute Treatment of Migraine: Results from a Double-Blind, Randomized, Placebo-Controlled Trial, Study 301
Title: A Phase 1 Study to Evaluate the Bioequivalence of Oral Tablet and Orally Dissolving Tablet Formulations of Rimegepant in Healthy Adult Subjects Under Fasting Conditions
Title: Rimegepant and BHV-3500, Small Molecule CGRP Receptor Antagonists, Exhibit No Active Vasoconstrictive Properties in Ex Vivo Human Coronary or Cerebral Arteries
Finally, Biohaven is also announcing that it will initiate a Phase 3 clinical trial of rimegepant for the prevention of migraine by the fourth quarter of 2018. This represents an expansion of the rimegepant clinical development program from a focus on the acute treatment of migraine to now include exploration of efficacy as a preventive therapy.
Dr. Coric commented, “We believe that rimegepant has the potential to confer both acute and prophylactic effects in a single therapeutic approach to treating migraine. Demonstrating potential prophylactic effects of rimegepant in a Phase 3 trial will be important to further characterizing its utility in migraine and differentiating from competitor products.”
Robert Croop, M.D., Biohaven’s Chief Development Officer – Neurology added, “The activity of rimegepant in our Phase 3 trials for the acute treatment of migraine and the evolving understanding of the utility of oral CGRP antagonists have prompted us to initiate a migraine prevention trial in order to explore the full potential of rimegepant in the treatment of migraine.”
The clinical trials were sponsored by Biohaven, which may benefit financially from the results. Dr. Lipton is a paid consultant and a stockholder of Biohaven.
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 consistently established across three randomized controlled trials to date: the two recently completed pivotal Phase 3 trials, and a previously reported Phase 2b trial. The co-primary endpoints achieved in the 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.
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. 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. The company’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 and BHV-3500’s potentially favorable cardiovascular profiles, 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 and the Company’s expected timelines for initiation, enrollment and completion of clinical trials and 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 May 15, 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