BOTHELL, Wash., April 23, 2019 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced that it will present additional analyses of the efficacy and quality of life data from clinical trials of eptinezumab, Alder’s lead investigational product candidate for migraine prevention, at the 71st Annual American Academy of Neurology (AAN) Meeting in Philadelphia being held May 4-10, 2019. On April 22, 2019, Alder announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for eptinezumab.
Eptinezumab data will be the subject of multiple platform and poster presentations, including a platform presentation on the data related to early onset of migraine prevention and consistency across four eptinezumab clinical trials. In-depth analyses will also be presented on patients’ global impression of change related to improvement in most bothersome migraine symptoms following treatment with eptinezumab. Additional presentations provide further assessments of eptinezumab’s efficacy and effects on quality of life.
“At Alder, we are deeply committed to giving people with migraine their lives back,” said Bob Azelby, presiden and chief executive officer of Alder. “We are excited for the presentation of data at AAN that further support eptinezumab’s clinical profile, including early and robust onset of prevention and benefits seen in patient-reported outcomes. These data continue to support the potential of eptinezumab to provide a meaningful treatment option for patients impacted with the burden of migraine, if approved.”
Session S17 – Headache: Clinical Trials I: Monday, May 6, 1:33 – 1:43 p.m. ET, Room 118C
- #004: Eptinezumab Demonstrates Early Relief from Episodic and Chronic Migraine: Consistency of Effect Across 4 Clinical Trials
- Presenter: Dr. David Dodick, professor of neurology, Mayo Clinic; chairman, American Migraine Foundation and president, International Headache Society
Session S38 – Headache: Clinical Trials II: Wednesday, May 8, 1:22 – 1:32 p.m. ET, Room 115A
- #003: Eptinezumab for the Prevention of Episodic Migraine Through 1 Year: Results from the Phase 3 PROMISE-1 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-1) Trial
- Presenter: Dr. Joel Saper, founder and director, Michigan Headache and Neurology Institute
Session S38 – Headache: Clinical Trials II: Wednesday, May 8, 2:28 – 3:38 p.m. ET, Room 115A
- #009: Patient Global Impression of Change Related to Improvement in Most Bothersome Symptom Following Treatment with Eptinezumab
- Presenter: Dr. Roger Cady, vice president of neurology, Alder BioPharmaceuticals and fellow, American Headache Society
Poster Session P1: Sunday, May 5, 11:30 a.m. – 6:30 p.m. ET; Presentations: 5:30 p.m. – 6:30 p.m. ET, Poster Neighborhood 10
- #10-023: Eptinezumab Reduces Migraine Frequency Within the First Month After Treatment in Patients with Episodic or Chronic Migraine
- Presenter: Dr. Paul Winner, director of both the Premiere Research Institute and the Palm Beach Headache Center in West Palm Beach, FL
- #10-025: Early Impact of Eptinezumab on the Health-Related Quality of Life (HRQoL) of Patients with Episodic or Chronic Migraine: SF-36 Analysis Across the Spectrum of Migraine
- Presenter: Dr. Merle Diamond, president and managing director, Diamond Headache Clinic in Chicago, IL
Poster Session P2: Monday, May 6, 11:30 a.m. – 6:30 p.m. ET; Presentations: 5:30 p.m. – 6:30 p.m. ET, Poster Neighborhood 10
- #10-006: Eptinezumab for Prevention of Chronic Migraine: Results of 2 Infusions in the Phase 3 PROMISE-2 (Prevention of Migraine with Intravenous Eptinezumab Safety and Efficacy-2) Trial
- Presenter: Dr. David Kudrow, director of both the California Medical Clinic for Headache and Headache Clinic Harbor-UCLA Medical Center; assistant clinical professor of neurology, UCLA David Geffen School of Medicine
- #10-007: Eptinezumab Meaningfully Improves Quality of Life (QoL) in Patients with Episodic or Chronic Migraine Within 1 Month After Treatment
- Presenter: Dr. Egilius L.H. Spierings, director and principal investigator, MedVadis Research Corporation near Boston, MA
- #10-020: Early Migraine Response by Month 1 and Clinically Meaningful Improvements in Health-Related Quality of Life (HRQoL) in Patients with Migraine in Phase 3 Trials of Eptinezumab
- Presenter: Dr. Stewart Tepper, professor of neurology, Geisel School of Medicine, Dartmouth; director, AHS Scottsdale Headache Symposium and editor-in-chief, Headache Currents
Poster Session P4: Wednesday, May 8, 11:30 a.m. – 6:30 p.m. ET; Presentations: 5:30 p.m. – 6:30 p.m. ET, Poster Neighborhood 10
- #10-024: Eptinezumab Increases Days Free from Canonical Migraine-Associated Symptoms Within 1 Month of Treatment in Patients with Chronic Migraine
- Presenter: Dr. Jack Schim, partner, The Neurology Center and co-director, Headache Center of California
Eptinezumab is an investigational monoclonal antibody (mAb) discovered and developed by Alder BioPharmaceuticals for migraine prevention. Eptinezumab was designed for 100% bioavailability delivered via infusion with high specificity and strong binding for rapid, robust, and sustained suppression of CGRP.
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. Alder’s lead product candidate, eptinezumab, is an investigational monoclonal antibody (mAb) delivered by infusion that inhibits calcitonin gene-related peptide (CGRP) for the prevention of migraine. If approved by the U.S. Food and Drug Administration, it will be the first infusion therapy for migraine prevention. Alder is also developing ALD1910, a preclinical mAb that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) for migraine prevention. For more information, please visit www.alderbio.com.
This press release contains forward-looking statements, including, without limitation, statements relating to: the clinical profile of eptinezumab; the continued development and clinical, therapeutic and commercial potential of eptinezumab; Alder’s commitment to giving people with migraine their lives back; the potential approval by the FDA of the BLA for eptinezumab; Alder’s focus on transforming the treatment paradigm for migraine patients; and the development of ALD1910. Words such as “will,” “committed,” “excited,” “support,” “potential,” “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; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the Securities and Exchange Commission (SEC) on February 25, 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.