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Data From Proof-of-Concept Clinical Trial of ALD403, a Monoclonal Antibody Against CGRP for the Prevention of Migraine, to be Presented at American Academy of Neurology Meeting

BOTHELL, Wash., April 23, 2014 (GLOBE NEWSWIRE) -- Alder Biopharmaceuticals Inc. today announced that Dr. Peter J. Goadsby, M.D., Ph.D., director, NIHR-Wellcome Trust Clinical Research Facility, King's College London and director, Headache Center, Department of Neurology, University of California, San Francisco, will present results from a randomized, double-blind, placebo-controlled proof-of-concept clinical trial of ALD403 for the prevention of frequent episodic migraine at the American Academy of Neurology Meeting, Friday, May 2, in Philadelphia, Pennsylvania.

Key points:

  • ALD403 met the primary endpoint of the study, significantly reducing mean migraine days per month versus placebo during weeks 5-8.
  • A single infusion of ALD403 resulted in a 100% decrease in migraine days per month for 27-41% of patients depending on month observed.
  • A single infusion of ALD403 resulted in 16% of patients having no migraines for the full 3 month study period, while 32% of patients had a 75% decrease in their migraine days for the full 3 month study period, statistically significant reductions (p=0.0001 and p=0.0004, respectively).
  • ALD403 was well tolerated and there were no differences from placebo in terms of adverse events or laboratory safety data.
  • ALD403 is a genetically engineered monoclonal antibody that targets CGRP for prevention of migraine. Calcitonin gene-related peptide (CGRP) is a small protein involved in the transmission of and heightened sensitivity to pain experienced in migraine.
  • The migraine prevention proof of concept trial was conducted in 163 patients with frequent episodic migraine who had on average 9 headache days per month. Patients were given a single intravenous dose of 1000mg of ALD403 or placebo and assessed for three months.
  • Dr. Goadsby's presentation entitled "Randomized, Double-blind, Placebo-controlled Trial of ALD403: An Anti-CGRP Peptide Antibody in the Prevention of Frequent Episodic Migraine" will be part of the clinical trials plenary session presented on Friday, May 2nd.

Quote:

Peter J. Goadsby, M.D., Ph.D., director, NIHR-Wellcome Trust Clinical Research Facility, King's College London and director, Headache Center, Department of Neurology, University of California, San Francisco, said, "The results of this study represent an important milestone for the development of new treatments for patients disabled by migraine. I am delighted that AAN selected this study evaluating ALD403 for the prevention of frequent episodic migraine as one of the emerging science abstracts for the conference this year."

About Alder Biopharmaceuticals

Alder Biopharmaceuticals Inc. is clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. The company's second therapeutic program, an investigational monoclonal antibody for migraine, ALD403, inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is now in clinical trials. Clazakizumab, previously known as ALD518, is Alder's investigational monoclonal antibody to the pro-inflammatory cytokine IL-6. Bristol-Myers Squibb is investigating the clazakizumab (as BMS-945429) in a Phase 2b clinical study in rheumatoid arthritis and other autoimmune indications based on a 2009 partnership. Alder's management team combines decades of industry experience with a proven track record for identifying and developing novel antibody therapeutics and enabling partners through the out-licensing of its technologies.

CONTACT: Media Contacts: David Schull or Andrea Flynn, Ph.D. Russo Partners (212) 845-4271 (646) 942-5631 david.schull@russopartnersllc.com andrea.flynn@russopartnersllc.comSource: Alder Biopharmaceuticals

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