“The whole process of going through with rimegepant, in terms of clinical trials, made this process even easier. There clearly is guidance that we and others have gotten from regulatory agencies across the globe on how to run these programs.”
The first patient was recently enrolled in a new phase 2/3 clinical trial (NCT04804033) of Biohaven’s third generation, highly soluble molecule zavegepant, which is a calcitonin gene-related peptide (CGRP) antagonist. The investigational oral agent will be assessed in 2 doses over 12 weeks, 100 mg and 200 mg.
Additionally, Elyse Stock, MD, chief medical officer, Biohaven, expressed that the company “plans [on] following the science of CGRP receptor antagonism into pain related disorders and non-migraine indications,” in a statement. In this first foray into migraine, zavegepant will be evaluated via a primary outcome of the number of migraine days during weeks 9 to 12, measured by the mean reduction from the baseline amount.
To find out more about the trial and the company’s experience in the CGRP space after its approval of rimegepant (Nurtec) over the last few years, NeurologyLive sat down with Stock. She outlined some of the details and expectations for the trial and shared her perspective on what’s been gleaned to advance Biohaven’s CGRP portfolio.
REFERENCE
Biohaven enrolls first patient in phase 2/3 trial of oral zavegepant, prompting $100 million milestone funding payment from Royalty Pharma. News release. March 29, 2021. Accessed April 5, 2021. https://www.prnewswire.com/news-releases/biohaven-enrolls-first-patient-in-phase-23-trial-of-oral-zavegepant-prompting-100-million-milestone-funding-payment-from-royalty-pharma-301257256.html
