Alder BioPharma (ALDR) Commences Second Pivotal Eptinezumab Phase 3 in Migraines

November 28, 2016 8:01 AM EST

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Alder BioPharmaceuticals, Inc. (Nasdaq: ALDR) announced the initiation of PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2), the second pivotal Phase 3 clinical trial of eptinezumab (formerly known as ALD403), 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.

“With the initiation of this second pivotal Phase 3 trial, we are continuing to execute on our plan to advance eptinezumab toward a planned BLA submission in 2018,” stated Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder. “Through our development plan, including upcoming top-line data from PROMISE 1 during the first half of 2017, we expect to differentiate eptinezumab as a unique and best-in-class therapeutic option for physicians in the treatment of their patients living with migraine.”

Key Points for PROMISE 2 and Eptinezumab Pivotal Clinical Trial Program:

  • 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 U.S. Food and Drug Administration (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.
  • The results of PROMISE 1, PROMISE 2 and the open-label study will support a Biologics License Application (BLA) submission to the FDA for the infusion formulation of eptinezumab.

Eptinezumab is the International Nonproprietary Name (INN) and official generic name given to the Alder drug candidate formerly known as ALD403 being developed for the prevention of migraine. The INN system is coordinated by the World Health Organization and is intended to make communication more precise by providing a unique standard name for each active ingredient.

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