Eptinezumab in new phase III trial for migraine- Alder BioPharmaceuticals

Alder BioPharmaceuticals announced the initiation of PROMISE 2, the second pivotal Phase III clinical trial of eptinezumab (formerly known as ALD 403), its monoclonal antibody candidate inhibiting calcitonin gene-related peptide (CGRP), for the prevention of migraine. Alder also announced today that eptinezumab was selected as the International Nonproprietary Name for ALD403. The PROMISE 2 pivotal study will evaluate the safety and efficacy of eptinezumab in patients with chronic migraine.

The double-blind, randomized, placebo-controlled trial will evaluate two dose levels of eptinezumab administered by infusion once every 12 weeks in approximately 1,050 individuals with chronic migraine. The primary endpoint of the trial is the mean reduction in migraine days from baseline over weeks 1 to 12. Key secondary endpoints are the 75% responder rate over weeks 1 to 12 as determined by the change in migraine days between eptinezumab and placebo, and the 75% responder rate over weeks 1 to 4 as determined by the change in migraine days between eptinezumab and placebo.

Top-line data from PROMISE 2 is expected in the first half of 2018. In addition to PROMISE 2, the eptinezumab pivotal trial program consists of PROMISE 1 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 1), Alder�s ongoing pivotal study evaluating eptinezumab in approximately 800 patients with frequent episodic migraine, and a planned open-label study. The open-label study is intended to confirm the long-term safety and tolerability of eptinezumab, as required by the FDA. This study is expected to begin in the first quarter of 2017 and will enroll approximately 120 patients that will receive eptinezumab administered by infusion every 12 weeks for one year.