Alder BioPharmaceuticals Inc. recently released the positive top-line data results from two of its clinical trials, which assessed ALD403, a proprietary monoclonal antibody product candidate to prevent migraines.
The company’s prevention approach specifically targets calcitonin gene-related peptide (CGRP).
The study, which lasted for 12 weeks, involved patients who have chronic migraines. The results suggest that ALD403 can rapidly stop the migraines.
“Today’s ALD403 Phase 2b data confirm and expand on our previous data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group,” Randall Schatzman, president and CEO of Alder, said. “Evaluation of ALD403 continues to exhibit a potential best-in-class profile, which includes immediate, significant and durable migraine prevention with infrequent quarterly dosing.”
In addition, the data suggests that using pharmacodynamics and pharmacokinetics with subcutaneous (SC), intravenous (IV) and intramuscular (IM) injections of the new prevention can be used in a quarterly single injection dosage approach.
“Today’s data also support our quarterly dosing strategy via a single intravenous, subcutaneous or intramuscular injection,” Schatzman said. “With our commitment to the accelerated development of ALD403 reinforced by today’s positive results, we look forward to advancing our development plan, and assuming FDA approval, independently marketing ALD403 in the U.S. to meet the critical medical needs of the 13 million patients nationwide who are candidates for migraine prevention therapy.”