“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.
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals, Inc., is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize genetically engineered therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Alder’s lead pivotal-stage product candidate, eptinezumab, is being evaluated for migraine prevention. Eptinezumab is a monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), a protein that is active in mediating the initiation of migraine. Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy. ALD1910 is a monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), another protein that is active in mediating the initiation of migraine. Clazakizumab, Alder’s third program, is a monoclonal antibody candidate that inhibits interleukin-6 and is licensed to Vitaeris, Inc. For more information, please visit http://www.alderbio.com.
This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of eptinezumab; the availability of results from clinical trials; the initiation and enrollment of future clinical trials; future regulatory filings and potential regulatory approval of eptinezumab. Words such as “continuing,” “execute,” “advance,” “planned,” “upcoming,” “expect,” “will,” “intended,” “support,” “potential,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder’s current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder’s ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder’s compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder’s ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with the development of eptinezumab; the sufficiency of Alder’s capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Alder’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2016, which was filed with the Securities and Exchange Commission (SEC) on October 27, 2016, and is available on the SEC’s website at www.sec.gov. Additional information will also be set forth in Alder’s other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Alder expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Alder’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.