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First Patients Dosed in Proof-of-Concept Clinical Study of Alder Biopharmaceuticals' Lead Therapeutic Candidate for Treatment of Migraine, ALD403
Date:3/20/2013

BOTHELL, Wash., March 20, 2013 /PRNewswire/ -- Alder Biopharmaceuticals Inc. today announced the dosing of the first patients in a proof-of-concept Phase 2 clinical study of its antibody therapeutic candidate, ALD403, targeting calcitonin gene-related peptide (CGRP) for treatment of migraine.

The double-blind, placebo-controlled, randomized study will evaluate the safety and efficacy of ALD403 administered monthly. One hundred and sixty patients with frequent, episodic migraines will be enrolled in the study across six sites for six months. Patients in the study will have experienced between four and 14 migraines per month in at least three months prior to enrollment and take acute migraine medication.

"Despite the enormous progress made in acute treatments for migraine, substantial unmet needs remain for patients experiencing multiple migraines per month," said Richard Lipton , M.D., principal investigator, professor of neurology and epidemiology at Albert Einstein College of Medicine in Bronx, New York, and director of the Montefiore Headache Center. "Most currently available preventive treatments for migraine are taken on a daily basis, reduce migraine frequency by 50 percent in about half of users and often produce significant side effects.  A biologic targeting CGRP and offering higher rates of efficacy, along with less frequent dosing and fewer side effects, could have a tremendous benefit for patients." 

Added Randall Schatzman , Ph.D., president and chief executive officer of Alder Biopharmaceuticals, "Alder is changing the paradigm for the treatment of migraine from abortive care at the time of migraine onset to a preventative approach, and our team has developed a highly specific therapeutic candidate with the potential to prevent the disorder before it begins that we believe has the ability
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SOURCE Alder Biopharmaceuticals Inc.
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