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News Release - July 31, 2017
Biohaven Initiates Second Pivotal Phase 3 Clinical Trial of Oral CGRP Antagonist for the Acute Treatment of MigraineNEW HAVEN, Conn, July 31, 2017 -- (Healthcare Sales & Marketing Network) -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it has commenced enrollment in the second of its two registrational Phase 3 clinical trials to evaluate the safety and efficacy of its orally-dosed rimegepant (BHV-3000) for the acute treatment of migraine.
"The launch of our second Phase 3 trial of rimegepant brings us one step closer to our goal of bringing an oral CGRP antagonist to market for patients suffering from migraine headaches," said Vlad Coric, M.D., Chief Executive Officer at Biohaven. "We believe our Phase 2b data with rimegepant shows that this investigational agent has the potential to be a best-in-class migraine treatment option, and its oral route of administration will spare patients the need for intravenous or subcutaneous administration associated with other CGRP antagonists in development."
Biohaven is conducting two double-blinded, placebo-controlled Phase 3 clinical trials to evaluate the efficacy and safety of 75 mg of rimegepant, Biohaven's innovative, orally-dosed small molecule CGRP receptor antagonist, for the acute treatment of migraine. The co-primary endpoints of the studies are freedom from pain at two hours post-dosing and a demonstrated effect on the patient's most bothersome symptom (nausea, photophobia or phonophobia) at two hours post-dosing. Patients in the Phase 3 clinical trials will be eligible to participate in a long-term safety study.
In a previously completed Phase 2b clinical trial, the 75 mg dose of rimegepant was observed to have achieved statistically significant improvement compared to placebo at two hours post-dosing on all four key migraine symptoms: pain, nausea, photophobia and phonophobia. To the company's knowledge, rimegepant is the only oral, small molecule CGRP receptor antagonist currently in development that has achieved statistically significant improvement on all four of these key migraine symptoms within a single study. Rimegepant-treated patients also experienced durable efficacy, achieving statistically higher rates of pain freedom at 24 and 48 hours post-dosing compared to placebo.
Rimegepant is the most advanced candidate in Biohaven's CGRP receptor antagonist platform. Biohaven is also pursuing the development of a second drug candidate (BHV-3500) for the treatment of patients with chronic and episodic migraine. Biohaven's CGRP platform is focused on delivering oral or intranasal therapies for migraine that are easy to use for patients – whenever and wherever a debilitating migraine attack occurs.
"Our clinical operations and development staff continues to demonstrate their proficiency in initiating large, multi-center clinical trials as we drive toward the timely completion of the efficacy studies needed for registration," said Elyse Stock, M.D., Chief of Portfolio Strategy and Development at Biohaven.
Biohaven's CGRP receptor antagonist platform has the potential to cover the full spectrum of migraine attacks with easy to use oral or intranasal formulations from prevention to acute treatment of migraine.
Migraine is both a widespread and disabling neurological disorder. The Migraine Research Foundation ranks migraine as the world's third most prevalent illness, affecting approximately 36 million people or 1 out of 4 households in the United States. Current treatment approaches, such as triptans, can be limited by headache recurrence within 24 hours after taking migraine medication, as well as cardiovascular contraindications and warnings.
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.
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, the potential results of the Company's ongoing Phase 3 clinical trials of rimegepant and the potential of rimegepant to be a best-in-class treatment option for the acute treatment of migraine, are forward-looking statements. The use of certain words, including the "believe" and "will" and similar expressions are 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 uncertainties relating to the future clinical success of rimegepant, and whether the results observed in the Phase 2b clinical trial will be observed in the Phase 3 pivotal trials. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on June 16, 2017. 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.
Source: Biohaven Pharmaceutical
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