NEW HAVEN, Conn., Nov. 27, 2017 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) announced today completion of enrollment in Study BHV3000-302, the Company’s second pivotal Phase 3 clinical trial examining the efficacy and safety of rimegepant in the acute treatment of migraine. The trial began shortly after the commencement of rimegepant’s first efficacy trial, Study BHV3000-301, and the two trials enrolled simultaneously with the objective of announcing topline results for the migraine program in the first quarter of 2018. Together the two pivotal trials enrolled approximately 3,000 subjects, which is expected to support a robust assessment of the efficacy of rimegepant in the acute treatment of migraine as required by the FDA for registration. Biohaven continues to evaluate the long-term safety of rimegepant in a third trial, Study BHV3000-201.
Rimegepant is a second generation, oral, calcitonin gene related peptide (CGRP) receptor antagonist being developed for the acute treatment of migraine. Rimegepant is, to the Company’s knowledge, only one of two small molecule CGRP-receptor antagonists in late stage clinical development. Biohaven is conducting two double-blind, placebo-controlled Phase 3 clinical trials to evaluate the efficacy and safety of 75 mg of rimegepant. The co-primary endpoints of the studies are freedom from pain at two hours post-dosing and freedom from the patient’s most bothersome symptom (nausea, photophobia or phonophobia) at two hours post-dosing. The Company is also pursuing development of its third generation CGRP-receptor antagonist, BHV-3500, for the acute and preventative treatment of migraine.
Vlad Coric, M.D., Chief Executive Officer at Biohaven, commented, “Completion of enrollment in this second migraine trial in only about four months underscores both the priority of the CGRP program within Biohaven and the very high unmet need for innovative therapies to better treat migraine attacks. Rimegepant was designed to be highly potent at the CGRP receptor and administered orally to allow convenient dosing by migraine sufferers when and where a migraine attack hits. We continue to efficiently advance our CGRP-receptor antagonist program as we strive to bring patients more therapeutic options in treating disabling migraines. I am pleased to report that we remain on track to receive topline results in these two Phase 3 trials in the first quarter of next year.”
Acute attacks of migraine can differ in intensity and frequency, with many being highly disabling. More than 90% of migraine sufferers are unable to work or