Biohaven Pharmaceutical Holding Company Ltd. 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.