- Data analyses from clinical trials to highlight eptinezumab’s efficacy and early, sustained quality of life improvements in the prevention of chronic migraine - - Preclinical data also to be presented for ALD1910, Alder’s second candidate for migraine, demonstrating its binding and selectivity to pituitary adenylate cyclase-activating peptide -
BOTHELL, Wash., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing therapeutic antibodies for the treatment of migraine, today announced that it will present data from its migraine prevention portfolio including two late-breaking presentations at IHC 2019, the 19th Congress of the International Headache Society, in Dublin, Ireland, being held from September 5-8, 2019. The data presentations will feature pharmacokinetic, efficacy and quality of life analyses from clinical trials for eptinezumab, an investigational monoclonal antibody (mAb) developed for the prevention of migraine and delivered by quarterly IV administration, and an evaluation of binding properties for ALD1910, Alder’s preclinical mAb also developed for the prevention of migraine.
“We continue to be encouraged by the positive data for both eptinezumab and ALD1910, representing two encouraging approaches to migraine prevention and reflecting progress in Alder’s dedication to forever transform migraine treatment,” said Paul Streck, M.D., chief medical officer of Alder BioPharmaceuticals. “Further, the data underscore the early quality of life impact of treatment with eptinezumab, an important patient-reported outcome given the debilitating effects of migraine extend beyond headache pain.”
Eptinezumab Data Eptinezumab is an investigational molecule under evaluation for the preventive treatment of migraine in adults. The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) filing for eptinezumab in April 2019, and set a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. If approved, eptinezumab will be the first-to-market IV therapy for migraine prevention.
Eptinezumab was designed for 100% bioavailability with high specificity and strong binding for targeted suppression of calcitonin gene-related peptide (CGRP). In a late-breaking poster presentation, an analysis will demonstrate eptinezumab’s deliberate design and engineering. Additionally, an oral presentation will demonstrate that a single IV administration of eptinezumab (100 mg or 300 mg)1 provided meaningful reductions in headache impact for chronic migraine patients measured at Month 1 and Month 3 compared to placebo, per the HIT-6 patient-reported measure of headache impact on daily life. A second oral presentation will cover a population pharmacokinetics analysis supporting IV administration of eptinezumab every 12 weeks, with 100 mg as the minimal clinically meaningful effective dose for migraine prevention.
Additionally, four posters will be presented featuring efficacy and quality of life improvements with eptinezumab demonstrated in various data analyses, and a fifth poster will include a post-hoc analysis supporting the conclusion that response to treatment with eptinezumab is not dependent on a patient’s genetic constitution.
ALD1910 Data Alder’s second candidate in development for migraine prevention, ALD1910, is designed to inhibit pituitary adenylate cyclase-activating peptide (PACAP), which has emerged as an important target for the treatment of migraine. It is being studied as a potential preventive treatment for those who have an inadequate response to other therapies and could provide another mechanism-specific therapeutic option for people with migraine and their physicians. A late-breaking presentation will feature a preclinical analysis validating that ALD1910 is a selective, high-affinity antibody that demonstrated in vivo functionality and engagement of PACAP.
Overview of Pesentations
Late-Breaking Presentations Poster Walk: Saturday, September 7, 2:30-3:30 p.m. GMT, Exhibition Hall at the Convention Centre Dublin
Late-Breaker Poster Number LB065: Anti-CGRP Monoclonal Antibody Eptinezumab Does Not Engage Fcy Receptors Involved in ADCC and ADCP, nor Does It Activate the Complement Cascade - Presenter: Carol J. Rapport, principal scientist, Alder BioPharmaceuticals
Late-Breaker Poster Number LB075: In Vivo Antagonistic Activity and Endogenous Target Engagement of an Anti-PACAP Monoclonal Antibody - Presenter: Cristina Moldovan Loomis, senior scientist, Alder BioPharmaceuticals
Oral Presentations
Oral Presentation Number OR18: HIT-6 Responder Rates After 1 and 3 Months of Eptinezumab Treatment - Presenter: Dr. Roger Cady, vice president of neurology, Alder BioPharmaceuticals and fellow, American Headache Society - Oral Comms 3 Session: Saturday, September 7, 10:40-10:50 a.m. GMT, Wicklow Hall 2
Digital Poster Number DPO32: Population Pharmacokinetics of Eptinezumab for the Preventive Treatment of Migraine - Presenter: Brian Baker, senior director toxicology and clinical pharmacology, Alder BioPharmaceuticals - Digital Session: Saturday, September 7, 3:02-3:08 p.m. GMT, Exhibition Hall Booth 3
Poster Presentations Friday, September 6, 9:00 a.m. – 5:30 p.m. GMT, Exhibition Hall at the Convention Centre Dublin
Poster Number PO165: Eptinezumab Increases Days Free from Canonical Migraine-Associated Symptoms Within 1 Month of Treatment in Patients with Chronic Migraine - Presenter: Peter Goadsby, professor of neurology, King’s College London and University of California, San Francisco
Poster Number PO167: Patient Global Impression of Change Related to Improvement in Most Bothersome Symptom Following Treatment with Eptinezumab - Presenter: Dr. Richard Lipton, director, Montefiore Headache Center, Albert Einstein College of Medicine
Poster Number PO183: Item Response Theory Analysis of the HIT-6 in Chronic Migraine Population - Presenter: RJ Wirth, president and managing partner, Vector Psychometric Group
Poster Number PO184: Validity Evidence of the HIT-6 Total Score in Sample of Patients with Chronic Migraine - Presenter: Carrie R. Houts, director of psychometrics, Vector Psychometric Group
Poster Number PO155: Genetic Assessment of Eptinezumab Response in the Prevention of Migraine - Presenter: Kira Misura, vice president R&D, Alder BioPharmaceuticals
About Alder BioPharmaceuticals, Inc. Alder BioPharmaceuticals is a clinical-stage biopharmaceutical company focused on transforming migraine treatment through the discovery, development and commercialization of novel therapeutic antibodies. The company’s mission is to forever change migraine treatment and give people with migraine their lives back. In 2019, Alder was ranked 19th among the top 100 fastest growing companies in Seattle by Growjo.
Eptinezumab, Alder’s lead product candidate for migraine prevention, is an investigational monoclonal antibody (mAb) that is delivered via IV and designed for 100% bioavailability with high specificity and strong binding for targeted suppression of calcitonin gene-related peptide (CGRP). If approved by the U.S. Food and Drug Administration, it will be the first-to-market IV therapy for migraine prevention. Alder is also developing ALD1910, a preclinical mAb designed to inhibit pituitary adenylate cyclase-activating peptide (PACAP) for migraine prevention. For more information, please visit www.alderbio.com.
Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements relating to: the potential approval by the FDA of the BLA for eptinezumab; the continued development of eptinezumab and the development of ALD1910; the clinical, therapeutic and commercial potential of eptinezumab and ALD1910; the belief that eptinezumab has the potential to be an important treatment option; and Alder’s mission to forever change migraine treatment and give people with migraine their lives back. Words such as “will,” “potential,” “continue,” “option,” 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: the clinical, therapeutic and commercial value of eptinezumab and ALD1910; 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 the build of Alder’s commercialization infrastructure; risks and uncertainties relating to the manufacture and supply 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 Alder's development and commercialization activities; 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 June 30, 2019, which was filed with the Securities and Exchange Commission (SEC) on August 6, 2019, 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.
Investor Relations Contact:
Sarah McCabe Stern Investor Relations, Inc. 212-362-1200 [email protected]
