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Biohaven Enrolls First Patient in Phase 2 Clinical Trial of Rimegepant, Oral CGRP Receptor Antagonist, for Treatment Refractory Trigeminal Neuralgia

NEW HAVEN, Conn., July 1, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, today announced that the first patient has been enrolled in a Phase 2 clinical trial assessing the efficacy and safety of rimegepant in treatment refractory trigeminal neuralgia. 

Biohaven Pharmaceuticals Logo (PRNewsfoto/Biohaven Pharmaceutical Holding)

Trigeminal neuralgia is a neuropathic pain disorder characterized by recurrent, paroxysmal, lancinating pain in the distribution of one or more branches of the trigeminal nerve.  These episodic bouts of severe facial pain can last seconds to minutes, occur several times per day, and often result in significant disability. The neuropeptide calcitonin gene-related peptide (CGRP) is thought to play an important role in the development of neuronal sensitization and neuropathic pain and its aberrant release from the trigeminal nerve has been implicated in the pathophysiology of trigeminal neuralgia. Rimegepant is Biohaven's lead oral, selective and potent small molecule calcitonin gene-related peptide (CGRP) receptor antagonist currently being developed for the treatment of migraine.

Robert Croop, M.D., Biohaven Chief Development Officer - Neurology , commented, "CGRP is an important mechanistic target that has been implicated in a variety of diseases.  Emerging evidence suggests that aberrant release of CGRP from the trigeminal ganglion plays a critical role in the development of pain syndromes such as trigeminal neuralgia. We believe this study is the oral first CGRP receptor antagonist being studied for use as a potential treatment of trigeminal neuralgia and extends our CGRP clinical research beyond migraine." 

This trial will enroll patients in a double-blind, placebo-controlled, crossover design at Johns Hopkins Medical Center. Researchers will evaluate the efficacy and safety of rimegepant in treating trigeminal neuralgia in patients who failed to respond adequately to pharmacotherapy.  The primary outcome measure is the change in a patient's average Numeric Pain Rating Scale between the two treatment phases of the study.  Additional details about the trial [NCT03941834] can be found at www.clinicaltrials.gov.

Melissa Wolfe Beiner, M.D., Director of Research and Development and Medical Lead for the Trigeminal Neuralgia development program at Biohaven commented, "Biohaven has worked closely with leading experts in the field from Johns Hopkins Medical Center, Dr. Tina Doshi and Dr. Michael Lim, to advance this Phase 2 clinical trial in patients with treatment refractory trigeminal neuralgia."  Dr. Wolfe Beiner added, " While trigeminal neuralgia is a rare disease, the patient burden associated with this disorder is significant.  We are excited about exploring the efficacy of rimegepant, our small molecule CGRP receptor antagonist, in the treatment of Trigeminal Neuralgia."

About Rimegepant

Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine and trigeminal neuralgia. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: three completed pivotal Phase 3 trials, and a Phase 2b trial.  The co-primary endpoints achieved in the three Phase 3 trials are consistent with regulatory guidance from the FDA and provided the basis for Biohaven's NDA submission to the FDA in the second quarter of 2019. More information about rimegepant can be found at the Company's website: https://www.biohavenpharma.com/science-pipeline/rimegepant

About Biohaven

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.

Forward-Looking Statements

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 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 expected issuance of preferred stock to Royalty Pharma, 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. 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, at Vlad.Coric@biohavenpharma.com

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