Biohaven Pharmaceuticals said it has begun human testing on another drug to treat migraines, following up on the launch of its first commercial migraine drug, Nurtec, earlier this year.
Biohaven is already in late-stage human testing of a nasal-spray version of its newer migraine drug, zavegepant (formerly vazegepant). The latest trial, recently greenlighted by the U.S. Food & Drug Administration, will test a version of the drug that can be taken by mouth.
Biohaven said Thursday it has administered the oral drug to its first patient in the Phase 1 study, which will assess its safety and how the medicine is absorbed and metabolized by the body.
The New Haven biotech plans to develop zavegepant for both migraine and non-migraine indications. The nasal spray version outperformed a placebo in a Phase 2-3 migraine study and is also being tested as a possible treatment for COVID-19.
Like Biohaven’s Nurtec, zavegepant is part of a new class of migraine drugs known as CGRP (calcitonin gene-related peptide) receptor antagonists. CGRP drugs work by blocking a brain chemical that transmits pain.
“We are excited to advance the oral formulations of zavegepant into human studies and broaden our CGRP franchise into migraine adjacencies, non-migraine indications and new formulations across the globe,” CEO Vlad Coric, MD, said in a statement.
Chief Scientific Officer Charles Conway said zavegepant is a structurally distinct CGRP drug that has unique chemical properties allowing administration in a variety of formulations.
“Zavegepant provides an opportunity to expand our CGRP program with customization of our products to different disease states based on the distinct attribute of each agent and formulation,” he said.
Biohaven in August secured up to $250 million to advance its zavegepant program under a funding deal with Royalty Pharma.
The agreement called for Royalty Pharma to pay Biohaven $150 million up front and $100 million when it begins Phase 3 testing on oral zavegepant. In exchange, Royalty will receive up to a 3 percent royalty on sales of the drug, plus milestone payments.
The New York-based company describes itself as the largest buyer of biopharmaceutical royalties and a leading funder of biopharmaceutical innovation.
Contact Natalie Missakian at news@newhavenbiz.com
