Data From Alder BioPharmaceuticals' Proof-of-Concept Clinical Trial Of ALD403 Published In Lancet Neurology Demonstrates ALD403 Effective In The Preventive Treatment Of Migraine

Alder BioPharmaceuticals Inc. (Nasdaq: ALDR), a clinical-stage biopharmaceutical company developing antibody therapeutics, today announced data from the proof-of-concept clinical trial of ALD403 published in the October 6, 2014 issue of Lancet Neurology demonstrates that ALD403 met the primary study endpoint and is effective for the preventative treatment of migraine. ALD403 is Alder's lead clinical candidate targeting the calcitonin gene-related peptide, or CGRP, for migraine prevention. CGRP is a small protein that is critically important in the transmission of and heightened sensitivity to pain experienced in migraine.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 26-41% of patients depending on the month observed. Clinical response to ALD403 was observed within the first month following a single administration and durable over the entire 3-month course of the study. The trial was conducted in 163 patients with 5 to 14 migraine days a month randomized to receive a single intravenous infusion of either 1000 mg ALD403 or placebo. There was no difference in adverse events or laboratory safety data between patients receiving ALD403 and placebo. Quote:Randy Schatzman, Ph.D., chief executive officer, Alder BioPharmaceuticals, said, "More than half of the 36 million patients suffering from debilitating migraine episodes are candidates for prevention. This study demonstrated that ALD403 can bring significant relief to patients who suffer from multiple migraine days every month of their lives. This represents a real breakthrough in the field and we look forward to initiating the Phase 2b IV formulation trial for the treatment of chronic migraine sufferers later this year as well as the Phase 2b subcutaneous formulation trial for the treatment of frequent episodic migraine sufferers in the first half of 2015."