Biohaven announced positive results today from its bioequivalence study with BHV-0223, an innovative sublingual formulation of riluzole. The study was designed to demonstrate pharmacokinetic equivalence of sublingual BHV-0223 compared to the reference listed drug Rilutek (riluzole), which is currently the standard of care treatment for patients with Amyotrophic Lateral Sclerosis (ALS). Topline results confirmed that sublingual BHV-0223 (40 mg) achieves bioequivalent exposures relative to Rilutek (50 mg). In the study, 138 healthy volunteers were administered BHV-0223 and Rilutek under fasted conditions. In the pre-specified primary analysis, BHV-0223 achieved area-under-the-curve and peak exposures of approximately 90% and 113%, respectively, compared to those generated by generic riluzole. The 90% confidence intervals were within the 80% to 125% range that is used to define bioequivalence.
Biohaven is developing BHV-0223 as a potential treatment for patients with ALS. Biohaven previously received regulatory feedback from the FDA that the Section 505(b)(2) pathway is acceptable for BHV-0223 in ALS, and that no additional efficacy or toxicology studies are necessary for submission of a new drug application (NDA) for this indication. With these positive results, Biohaven will advance towards completing an NDA with the goal of submitting in the first half of 2018.
BHV-0223 is designed to meet the needs of patients with ALS. BHV-0223 is an innovative, sublingually administered orally dissolving tablet (ODT) that makes use of the unique Zydis® ODT fast-dissolve technology. It is being developed under an exclusive, worldwide agreement with Catalent. While riluzole is FDA-approved for ALS, conventional tablets may be difficult to administer to ALS patients, who often have dysphagia or trouble swallowing. By contrast, when BHV-0223 is placed under the tongue, it dissolves in seconds and does not require swallowing. In addition, riluzole is associated with dose-dependent effects on liver tests (transaminases). BHV-0223 offers bioequivalent exposures compared to Rilutek with a 20% lower dose. That is, sublingual administration of 40 mg BHV-0223 results in bioequivalent blood exposures to orally ingested 50 mg tablets of Rilutek. Based on this observation and reduced drug exposure to the liver, BHV-0223 may have a lessened risk for causing liver test elevations.
Vlad Coric, M.D., Chief Executive Officer of Biohaven, commented, "We are very excited about favorable results from the current study establishing the bioequivalence of our innovative sublingually administered BHV-0223. Sublingual BHV-0223 is unique in that it is a Zydis® orally dissolving tablet (ODT) formulation, that is optimized to allow administration to patients with dysphagia and to provide therapeutic blood levels with a lower milligram dose for all patients suffering from ALS."
Rob Berman M.D., Chief Medical Officer added, "This is a meaningful advancement for patients with ALS, especially those who would be able to continue taking riluzole despite difficulties swallowing. In addition, the possibility to achieve a therapeutic exposure with a lower drug dose would make BHV-0223 more amenable to those patients with concerns about liver toxicity."
Beyond the current advance with BHV-0223, Biohaven is making progress across its oral, small molecule calcitonin gene receptor peptide (CGRP) antagonist for the treatment of migraine and glutamate modulation technology platforms for neurodegenerative diseases with high unmet need.
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, 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.
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