BOTHELL, Wash., July 25, 2016 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced top-line 24-week data demonstrating persistent migraine prevention in a Phase 2b clinical trial evaluating ALD403 in patients with chronic migraine. ALD403 is Alder’s proprietary monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide (CGRP). In March 2016, Alder reported that the Phase 2b study met both the primary efficacy endpoint, a 75% reduction in migraine days over 12 weeks, and the secondary efficacy endpoint of mean reduction in migraine days from baseline.
“The 24-week data confirm and extend our previously reported 12-week data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group. These data will help us finalize the dose selection and design of PROMISE 2, our second planned pivotal trial on track to start later this year,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. “Additionally, the data validate the dose selection for the ongoing PROMISE 1 study and further demonstrate ALD403’s best-in-class potential as evidenced by prolonged migraine prevention after a single injection. Reinforced by these positive results, we will continue to advance our development plan and, assuming regulatory approval, commercialize ALD403 in the U.S. to meet the needs of the approximate 13 million Americans who are candidates for a migraine preventative therapy.”
Read more: https://globenewswire.com/news-release/2016/07/25/858569/0/en/Alder-Reports-Positive-Top-Line-24-Week-Data-Demonstrating-Persistent-Migraine-Prevention-in-Phase-2b-Study-of-ALD403-in-Patients-with-Chronic-Migraine.html