Biohaven Enrolls First Patient in Phase 2/3 Sinusitis Trial of Nurtec® ODT

NEW HAVEN, Conn., Feb. 22, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, today announced that it has commenced enrollment in a Phase 2/3 clinical trial assessing the efficacy and safety of Nurtec® ODT (rimegepant) 75 mg in patients with chronic rhinosinusitis (CRS) with or without nasal polyps.

Nurtec ODT is an oral calcitonin-gene related peptide receptor antagonist currently approved for the acute and preventive treatment of migraine. Prior research has implicated CGRP in the pathophysiology of the disease and suggested therapeutic benefits of CGRP antagonism.

Daniel Franjic, M.D., Medical Director at Biohaven, stated, "Chronic rhinosinusitis remains an area of significant healthcare burden to patients, with a high unmet need for disease-specific interventions. CGRP is hypothesized to play a role in the pathophysiology of sinus congestion and pain. This study will evaluate the safety and efficacy of Nurtec ODT in the acute treatment of patients suffering from chronic rhinosinusitis. We are excited to explore the potential of a novel therapeutic option for patients."

CRS affects approximately 5-12% of the general population and is associated with reduced quality of life and significant patient burden. CRS is a symptomatic inflammation of the paranasal sinuses and nasal cavity lasting more than 12 weeks. Typically, it manifests as facial pain/pressure/fullness, nasal obstruction (congestion), nasal discharge, and/or decreased sense of smell. Broadly, it can be divided into two phenotypes, CRS with and without nasal polyps, with approximately 20% patients having nasal polyposis.

Nissim Khabie, M.D., an Otolaryngologist with ENT Specialty Care in Minneapolis, said, "In my experience treating CRS patients for over two decades, this is a serious disease that presents a substantial burden to our patients. I am excited for the prospect of a novel treatment pathway to alleviate suffering and disability in this population."

Biohaven expects to enroll approximately 200 patients in this randomized, double-blind, placebo-controlled trial across approximately 25 sites in the United States. Researchers will evaluate acute symptomatic treatment with rimegepant in patients with chronic rhinosinusitis with and without nasal polyps. The primary outcome measure is the change in a patient's facial pain/pressure/fullness score on a Numerical Rating Scale (0-10). The trial will also assess the safety and tolerability of rimegepant. Additional details about the trial can be found at www.clinicaltrials.gov (NCT05248997).

Gary Berman, M.D., Clinical Assistant Professor, University of Minnesota, commented, "I am thrilled that Biohaven has enrolled the first patient in their chronic rhinosinusitis clinical trial. Patients with CRS have few medical options. Nurtec ODT may offer a new therapeutic choice."

CGRP Receptor Antagonism

Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. CGRP receptor antagonists work by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. Studies have proposed that CGRP contributes to nasal secretion by inducing sustained arterial vasodilation, increasing nasal blood flow, and possibly by increasing plasma flux across fenestrated capillaries. In a clinical study, intranasal administration of CGRP in healthy volunteers resulted in increases in blood flow, the sensations of obstruction, headache, and mild sneezing. Another study in patients with chronic rhinosinusitis found that nasal mucosa CGRP levels correlated with symptom intensity and the number of inflammatory cells. In a preclinical study, CGRP (8-37) peptide antagonist attenuated the capsaicin-induced vasodilation and decrease in nasal cavity volume, suggesting that CGRP is an important mediator of nasal vascular changes resulting from activation of C-fiber afferents.

About NURTEC ODT

NURTEC® ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily to treat or every other day to help prevent migraine attacks. For more information about NURTEC ODT, visit www.nurtec.com. The most common adverse reaction was nausea and abdominal pain/indigestion. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

About Biohaven

Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's Neuroinnovation™ portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute and preventive treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis. 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 regarding the safety and efficacy of Nurtec ODT in the acute treatment of patient suffering from chronic rhinosinusitis and the completion of the Phase 2/3 clinical trial described in this release. 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 Biohaven's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 1, 2021, and Biohaven's subsequent filings with the Securities and Exchange Commission. The forward-looking statements are made as of this date and Biohaven 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.

NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

Biohaven Contact:
Dr. Vlad Coric
Chief Executive Officer
[email protected]

Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502

SOURCE Biohaven Pharmaceutical Holding Company Ltd.