Date: 2015-05-15
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 17th Congress of the International Headache Society in Valencia, Spain
Company: Alder Biopharmaceuticals (USA - WA)
Product: ALD403
Action
mechanism: monoclonal antibody. ALD403 is a monoclonal antibody targeted to calcitonin gene-related peptide, or CGRP, for migraine prevention. CGRP is a validated target that is believed to play a key role in migraine.
Disease: prevention of frequent episodic migraine
Therapeutic area: CNS diseases
Country:
Trial details:
Latest
news: * On May 15, 2015, Alder BioPharmaceuticals, a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, announced that six-month follow-up data from its Phase 2 proof of concept clinical trial of ALD403, its anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of frequent episodic migraine, were presented by Jeffrey T.L. Smith, M.D., FRCP, Senior Vice President, Translational Medicine at Alder, in an oral presentation at the
17th Congress of the International Headache Society in Valencia, Spain. Key Points from Oral Session: Migraine Pathophysiology and CGRP as a Therapeutic Target:
• A single intravenous dose of ALD403 1000mg demonstrated prolonged efficacy over six months for the preventive treatment of migraine.
• Over three months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 61% vs 33% (p < 0.001); 33% vs 9% (p < 0.001); and 16% vs 0% (p < 0.001), respectively.
• Over six months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 53% vs 28% (p < 0.001); 26% vs 7% (p <0.002); and 11% vs 0% (p <0.002), respectively.
• 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 dose of 1000mg of ALD403 or placebo. The primary
endpoint was the mean change in migraine headache days from baseline to weeks 5-8, and patients were followed for 24 weeks for additional safety and efficacy analyses. Alder BioPharmaceuticals works to identify the optimal once-quarterly dose of ALD403 for both infusion and self-administration formulations. To this end, the companynow plans to initiate two additional dose-ranging clinical trials in the second half of this year.
