Market Overview

Alder Presents Positive Clinical Data for ALD403 at the Annual Meeting of the American Headache Society

Share:

BOTHELL, Wash., June 09, 2016 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced the presentation of data from Phase 2b and Phase 1 clinical trials of ALD403 for the prevention of migraine, and preclinical data from a case study of ALD403 and other CGRP-antibodies at the 58th Annual Scientific Meeting of the American Headache Society in San Diego.

Key Points:

Oral presentation by Jeffrey T.L. Smith, M.D., FRCP, Senior Vice President, Translational Medicine at Alder: "Randomized, Double-Blind, Placebo-Controlled Trial of ALD403, an Anti-CGRP Peptide Antibody in the Prevention of Chronic Migraine"

  • A single intravenous (IV) dose of ALD403 100 mg or 300 mg met the primary efficacy endpoint of the trial, a 75% reduction in migraine days over the entire 12 weeks in 33% and 31% of patients, respectively (p < 0.05)
  • A single administration of ALD403 resulted in an immediate and durable mean reduction in migraine days from baseline throughout the 12 weeks at the 300 mg (p < 0.005), 100 mg (p < 0.01) and 30 mg (p < 0.005) dose levels, meeting the secondary efficacy endpoint
  • The 10 mg dose was identified as sub-therapeutic
  • The safety profile was consistent with earlier ALD403 clinical trials; no drug related safety signals were identified in this trial

Poster presentation: "A Multiple Dose, Placebo-Controlled, Randomized Phase I Clinical Trial of ALD403, a Humanized anti-Calcitonin Gene-Related Peptide Monoclonal Antibody, Administered Once Every 3-Months via IV, SC, or IM – Pharmacokinetic and Pharmacodynamic Results"

  • The pharmacokinetic and pharmacodynamic results support further evaluation in later stage clinical trials of 100 mg ALD403 IV, subcutaneous (SC), or intramuscular (IM), or 300 mg IM administration, once every three months
  • IM injections of ALD403 result in higher absolute bioavailability for ALD403 when compared to the SC route
  • High absolute bioavailability combined with a higher accumulation ratio resulted in increased overall exposure to ALD403 after IM administration relative to IV or SC as determined by the dose normalized AUC values following the second treatment

Poster presentation: "A Characterization of the CGRP-Antibody Interactions of Therapeutic Antibodies Effective in Preventing Migraine: a Comparative Pre-Clinical Case Study of ALD403 and Other CGRP Antibodies"

  • Preclinical data comparing the binding kinetics of ALD403 to two other anti-CGRP monoclonal antibodies demonstrated that subtle differences in antibodies targeting the same ligand can alter characteristics important for leveraging a particular therapeutic axis and optimizing commercial as well as clinical utility
  • The data generated from the three anti-CGRP antibodies engineered into a common immunoglobulin scaffold demonstrated differences in the intrinsic binding features among the antibodies tested
  • ALD403 bound differentially from the other anti-CGRP antibodies studied, and bound to CGRP with high affinity and rapid target engagement

Quote:

Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder, said, "We are encouraged by the data presented from these studies, and believe they demonstrate the potential for ALD403 to be a best-in-class therapeutic, with robust and immediate migraine prevention via a single infrequent quarterly administration. A 75% reduction in migraine days for patients with chronic migraine, a severe form of the disease, can transform the lives of patients by giving them back roughly two weeks of their lives each month. Additionally these data support a quarterly, single injection dosing strategy with ALD403 and multiple routes of administration to provide patients with convenience and flexibility. We are continuing to advance the ALD403 development program and expect to announce 24-week data from our Phase 2b study in chronic migraine in the third quarter and to initiate PROMISE 2 later in the year, the second of two planned pivotal clinical trials intended to support a biologic license application submission to the U.S. Food and Drug Administration."

About Alder BioPharmaceuticals, Inc.

Alder BioPharmaceuticals, Inc., is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. ALD403, Alder's lead pivotal-stage product candidate being evaluated for migraine prevention, is a genetically engineered monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP). CGRP is a small protein with a well-established role in the initiation, transmission and heightened sensitivity to migraine pain. Alder's second program, ALD1613, targets adrenocorticotropic hormone (ACTH) and is intended for the treatment of congenital adrenal hyperplasia and Cushing's disease. ALD1613 is undergoing Investigational New Drug (IND)-enabling preclinical studies, and an IND submission is planned for 2016. Additionally, clazakizumab, a monoclonal antibody therapeutic candidate discovered by Alder designed to block interleukin-6, 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 ALD403 and ALD1613; the initiation of future clinical trials and studies; and future regulatory filings.  Words such as "encouraged," "believe," "potential," "can," "support," "continuing," "advance," "expect," "intended," "planned," 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 ALD403 and ALD1613 to demonstrate safety and efficacy in clinical testing; the availability of data at the expected times; the clinical, therapeutic and commercial value of ALD403 and ALD1613; risks and uncertainties related to regulatory review and approval processes and Alder's compliance with applicable legal and regulatory requirements; 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 March 31, 2016, which was filed with the Securities and Exchange Commission (SEC) on April 28, 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.

Media Contacts: David Schull or Lena Evans Russo Partners, LLC (212) 845-4271 (212) 845-4262 david.schull@russopartnersllc.com lena.evans@russopartnersllc.com Investor Relations Contact: David Walsey Alder Biopharmaceuticals (425) 408-8032 ir@alderbio.com

Primary Logo

View Comments and Join the Discussion!