Biohaven Pharmaceutical has concluded patient enrolment in the second Phase III clinical trial (Study BHV3000-302) of its drug candidate rimegepant for the acute treatment of migraines.
Rimegepant is an oral, second-generation antagonist of calcitonin gene-related peptide (CGRP) receptor.
The double-blind, placebo-controlled Phase III trial is designed to evaluate the safety and efficacy of 75mg rimegepant.
Study BHV3000-302 is set to measure the co-primary endpoints of freedom from pain and patient’s most bothersome symptom such as nausea, photophobia or phonophobia at two hours after dosing.
Biohaven Pharmaceutical CEO VladCoric said: “Completion of enrolment in this second migraine trial in only about four months underscores both the priority of the CGRP programme 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.”
Earlier this month, the firm announced the completion of patient recruitment in another Phase III trial, Study BHV3000-301, of rimegepant for the acute treatment of a migraine.
With a total of about 3,000 subjects, both the trials are scheduled to report top-line data in the first quarter of next year.
The findings from this Phase III migraine programme are expected to support the efficacy of the investigational agent as required for registration by the US Food and Drug Administration (FDA ).
The firm has also recently obtained agreement from the FDA on the initial paediatric study plan (iPSP) for orally dosed rimegepant.