- Alder BioPharmaceuticals chronic migraine drug succeeded in a mid-stage trial, boosting the biotech's fortunes as it looks to keep pace with industry competitors Amgen, Eli Lilly, and Teva in the therapeutic space, the company said on Monday.
- The drug, known as ALD403, reduced the number of "migraine days" by 75% in roughly a third of patients receiving the two highest dose levels over 12 weeks. Additionally, a single dosing proved to durably reduce migraine days over the entire 12 weeks, backing up a quarterly dosing strategy.
- ALD403 inhibits calcitonin gene-related peptide (CGRP), a protein which is known to trigger the pain tied to migraines. Amgen, Lilly, and Teva are also developing drugs which target this same protein.
Alder's stock jumped sharply higher on the news, as investors took encouragement from the positive efficacy data. Among the drugs in Alder's pipeline, ALD403 is the farthest along in development. The biotech company is also pursuing an indication for the treatment of high-frequency migraine and has begun a pivotal trial studying ALD403 in patients suffering from these frequent episodic 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. Evaluation of ALD403 continues to exhibit a potential best-in-class profile, which includes immediate, significant and durable migraine prevention with infrequent quarterly dosing," said Alder CEO Randall Schatzman.
Chronic migraine patients are defined as those patients who suffer at least 15 headache days a month, and of which 8 can be classified as migraine days.
After 12 weeks, the 300 mg and 100 mg dose levels of the drug led to a 75% reduction in the migraine days in 33% and 31% of patients, respectively. Additionally, ALD403 met its secondary objective of a single administration resulting in an immediate and durable reduction of the number of migraine days.
According to the Migraine Research Foundation, 36 million Americans experience migraines. Other drugs taken to prevent migraines, like Botox or beta blockers, often have side effects which limit use of the drugs.