Biohaven Pharmaceutical said that the FDA has approved the company’s IND for a Phase 2 study of its vazegepant intranasal calcitonin gene-related peptide (CGRP) receptor antagonist for the reduction of excessive immune response leading to lung injury in COVID-19 patients. Biohaven recently announced that it would advance vazegepant (BHV-3500) into Phase 3 development for the treatment of migraine.
The Phase 2 safety and efficacy study in patients with COVID-19 who require supplemental oxygen will compare intranasal vazegepant to placebo in the resolution of pulmonary symptoms, need for ventilator support, and death. The study will be conducted by researchers at Thomas Jefferson University.
Biohaven CEO Vlad Coric commented, “Given the unprecedented global threat to life that COVID-19 infection represents, there is an urgent need to test novel approaches to mitigating the consequences of the infection, including reducing the hyper-immune reaction that drives much of the morbidity and mortality in the pulmonary effects of this viral disease. This pandemic is a call to action for our entire industry. I am grateful to our collaborators at the pulmonary institute at Thomas Jefferson and the team at Biohaven that moved so quickly to develop a clinical protocol and submit this IND to the FDA in the weeks after the pandemic first developed. We owe a debt of gratitude to the scientists at the NIH, FDA, academic centers and pharmaceutical companies who are working hard to study therapies that might battle this terrible disease — the innovative efforts of the true unsung scientific heroes of this crisis will only be fully recognized once better treatments are developed to treat COVID-19.”
Read the Biohaven Pharmaceuticals press release.
