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Data From Phase 2b Clinical Trial of Clazakizumab, an Anti-IL-6 Monoclonal Antibody for the Treatment of Active Psoriatic Arthritis, to be Presented at the American College of Rheumatology Annual Meeting

BOTHELL, Wash., Nov. 15, 2014 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. ("Alder") (Nasdaq:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, autoimmune and inflammatory diseases, today announced Philip J. Mease, M.D. will present data from a randomized, double-blind, placebo-controlled, dose-ranging multicenter Phase 2b clinical trial evaluating the safety and efficacy of Clazakizumab in adults with active psoriatic arthritis at the American College of Rheumatology Annual Meeting at the Boston Convention and Exhibition Center in Boston, MA.

Key points:

  • The oral presentation, "A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Evaluate the Efficacy and Safety of Clazakizumab, an Anti-IL-6 Monoclonal Antibody, in Adults with Active Psoriatic Arthritis," will be presented Sunday, November 16, 2014, from 4:30 to 4:45 p.m.
  • The presentation, number 947, is part of the Spondyloarthropathies and Psoriatic Arthritis II session held in room 258 B.
  • Clazakizumab met the primary endpoint of the study, ACR20 response rate at week 16 versus placebo.
  • At week 16, ACR20 response rates were 29.3, 46.3, 52.4 and 39 percent for placebo, and 25, 100 and 200 mg Clazakizumab, respectively.
  • While there was no clear dose response, ACR 20/50/70 response rates were higher than placebo for all Clazakizumab treatment arms at week 24.
  • Clazakizumab was well tolerated and there were no differences from placebo in terms of adverse events or laboratory safety data.
  • Clazakizumab is a humanized, monoclonal antibody, designed to block the pro-inflammatory molecule interleukin-6 (IL-6), which plays a key role in the inflammatory cascade leading to the inflammation, swelling, pain and destruction of large and small joints associated with arthritis.
  • Additional presentations include the posters:
    • "Validation of a Prognostic Model to Predict Structural Damage Assessed by X-ray in Patients with RA Using MRI Data from a Clinical Trial," #385, Poster Session A, Sunday, Nov. 16, 2014, from 8:30 a.m.-4:00p.m.
    • "Impact of Rapid Attainment of Target Measures in Rheumatoid Arthritis on Patient Reported Outcomes," #1362, Poster Session B, Monday, Nov. 17, 2014, from 8:30 a.m.-4:00p.m.

Quote:

Randall C. Schatzman, Ph.D., President and Chief Executive Officer, Alder BioPharmaceuticals, said, "The results of this study in psoriatic arthritis are an important milestone for the development of Clazakizumab. Having recently regained control of this novel therapy, we are excited to share this promising data and plan to announce top-line data from a follow-on Phase 2b dose-ranging trial for the treatment of rheumatoid arthritis in the first half of 2015. At this time, based on positive data for Clazakizumab reported to date, we are actively seeking a strategic partner that can further develop and commercialize this promising therapeutic in autoimmune and inflammatory diseases."

About Alder BioPharmaceuticals

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. Alder's ALD403 inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is now undergoing clinical testing. Alder advanced ALD403 into a Phase 2b trial for the treatment of chronic migraines and plans to initiate a Phase 2b trial for the treatment of frequent episodic migraines in the first half of 2015. Alder's second program, Clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed a Phase 2b clinical study. For more information, please visit http://www.alderbio.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding our expectations for the initiation of future clinical trials, data availability from ongoing clinical trials and the potential of ALD403 and Clazakizumab to address the unmet medical needs of patients. All forward-looking statements included in this press release are based on our management's beliefs and assumptions and on information currently available to our management, and we assume no obligation to update any such forward-looking statements. Any or all of our forward-looking statements in this press release may turn out to be wrong and actual events or results may differ materially. Our forward-looking statements can be affected by inaccurate assumptions we might make or by known or unknown risks, uncertainties and other factors. In evaluating these statements, you should specifically consider various factors, including the risks outlined under the caption "Risk Factors" set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, which was filed with the Securities and Exchange Commission (the "SEC") on November 3, 2014, and is available on the SEC's website at www.sec.gov. Additional information will also be set forth in our other reports and filings we will make with the SEC from time to time. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.

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.com Investor Relations Contact: Sarah McCabe Stern Investor Relations, Inc. (212) 362-1200 sarah@sternir.comSource:Alder BioPharmaceuticals