BOTHELL, Wash., June 07, 2017 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), today announced four data presentations at the 59th Annual Scientific Meeting of the American Headache Society in Boston from June 8-11, 2017. The presentations will highlight Phase 2b clinical data and analyses for eptinezumab (formerly ALD403), Alder’s investigational monoclonal antibody currently in Phase 3 clinical trials for migraine prevention.
“Alder is excited to present some of the encouraging eptinezumab clinical data observed to date, which we believe continues to support eptinezumab as a potential therapy for migraine prevention, including meaningful migraine prevention activity within 24 to 48 hours following a single administration,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. “We expect to announce top-line results from PROMISE 1, our pivotal Phase 3 trial evaluating eptinezumab in patients living with frequent episodic migraine, before the end of the month. We are focused on moving efficiently through our second Phase 3 pivotal trial, PROMISE 2, and toward a BLA submission in the second half of 2018.”
Presentation Details:
Oral presentation on Saturday, June 10, 2017 from 8:50 am – 9:00 am ET by Jeffrey T.L. Smith, M.D., FRCP, Senior Vice President, Translational Medicine at Alder: “Randomized, Double-blind, Placebo-controlled Trial of ALD403 (eptinezumab), an Anti-CGRP Monoclonal Antibody for the Prevention of Chronic Migraine”
Poster presentation on Friday, June 9, 2017: “ALD403 (eptinezumab) Elicits Meaningful Reductions in Migraine Activity 24 Hours After a Single Intravenous Administration”
Poster presentation on Friday, June 9, 2017: “Responders to ALD403 (eptinezumab) Show Significant Reduction in Headache Impact at Weeks 4 through 12 Following a Single Infusion in Chronic Migraine”
Poster presentation on Friday, June 9, 2017: “Rational Design of a Monoclonal Antibody Inhibiting Calcitonin Gene-Related Peptide, ALD403 (eptinezumab), for the Prevention of Migraine”
About Eptinezumab
Eptinezumab, formerly ALD403, is Alder’s lead pivotal-stage investigational product candidate in development as a migraine prevention treatment for patients with chronic and frequent episodic migraine. Eptinezumab is a novel monoclonal antibody that inhibits the calcitonin gene-related peptide, or CGRP, a small protein involved in the transmission of, and heightened sensitivity to, pain experienced in migraine.
About Alder BioPharmaceuticals
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.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of eptinezumab (formerly ALD403); the availability of results from clinical trials; and the potential regulatory submission for eptinezumab. Words such as "will," “support,” "potential," "expect," "focused," "toward," 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 year ended March 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on April 27, 2017, 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.