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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 2^nd.
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