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Data Show Single Dose of ALD403 Reduces Migraines for Six Months
A single intravenous dose of ALD403 (Alder BioPharmaceuticals, Inc.) demonstrated prolonged efficacy over six months for the preventive treatment of migraine, according to data from a phase 2 proof-of-concept trial presented at the 17th Congress of the International Headache Society in Spain.
Over three months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 61% versus 33%, 33% versus 9%, and 16% versus 0%, respectively. Over six months, those proportions were 53% versus 28%, 26% versus 7%, and 11% versus 0%.
ALD403 was well tolerated and there were no differences from placebo in terms of adverse events or laboratory safety data.
The migraine prevention proof-of-concept trial was conducted in 163 patients with frequent episodic migraine who had on average nine headache days per month. Patients were given a single intravenous 1,000-mg dose of ALD403 or placebo. The primary endpoint was the mean change in migraine headache days from baseline to weeks 5 to 8, and patients were followed for 24 weeks for additional safety and efficacy analyses.
ALD403 is an anticalcitonin gene-related peptide (CGRP) antibody for the prevention of frequent episodic migraine. CGRP is a small protein involved in the transmission of and heightened sensitivity to pain experienced in migraine.
￼￼“We believe that ALD403 has the potential to transform migraine prevention,” said Randall C. Schatzman, PhD, President and Chief Executive Officer of Alder. The company is now focused on identifying the optimal once-quarterly dose of ALD403 for infusion and self-administration formulations. It plans to initiate two additional dose-ranging clinical trials in the second half of this year.
ALD403 is undergoing phase 2b clinical testing for the treatment of chronic migraines. Alder plans to initiate additional advanced clinical studies for ALD403 in frequent episodic and chronic migraines in the second half of 2015.
Source: Alder BioPharmaceuticals, Inc.; May 15, 2015.