Alder BioPharmaceuticals announced that eptinezumab, its lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP), met the primary endpoint in its pivotal Phase 3 PROMISE 2 clinical trial with very high statistical significance for both dose levels tested in the trial following a single quarterly infusion. 

In addition, eptinezumab met all key secondary endpoints with very high statistical significance vs. placebo including prevention. Furthermore, 15% of eptinezumab patients had no migraines for a full three months. 

“These clinically significant data clearly demonstrate that eptinezumab delivered by infusion provided rapid, effective and sustained migraine relief,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. “With these PROMISE 2 results, we remain on track to submit our Biologics License Application (BLA) in the second half of 2018. 

More than 2,600 patients have been treated with eptinezumab in its clinical development program, including the PROMISE 1 and PROMISE 2 trials.