Alder Biopharmaceuticals Inc (NASDAQ:ALDR) recently took the opportunity at the American Headache Society meeting in San Diego to present data from clinical trials of its compound ALD403. The compound is being developed as a drug for treating migraines.
Alder presented data relating to Phase 2b and Phase 1 trials of ALD403. It also outlined the possible pathway for the compound as it moves toward seeking regulatory approval for marketing clearance.
How did ALD403 perform?
According to Alder’s SVP of Translational Medicine Jeffrey T.L. Smith, various doses of ALD403 were tested in patients against a placebo in a double-blind randomized study. For background, ALD403 is an anti-CGRP antibody designed to prevent chronic migraines.
In the study, the compound was administered in doses of 10mg, 30mg, 100mg and 300mg. In the 100mg and 300mg doses, the drug met the primary efficacy endpoint of the trial. This constituted a 75% drop in migraine days over the 12 weeks of the study.
The details shared by Alder show that 33% of the patient in the 100mg dose group registered a 75% reduction in their migraine days. In the 300mg cohort, 31% of the patients registered a similar decline in their migraine days. Thus, ALD403 offered patients some much-needed relief as the study sought to establish.
Additionally Alder reported that when patients received a single administration of ALD403, they experienced a near-instant and durable drop in their migraine days at 30mg, 100mg and 300mg dose levels. With that, Alder declared that ALD403 also meet its secondary efficacy endpoint.
Although a 10mg dose was involved in the trial, ALDR said it was mainly a sub-therapeutic dose.
How safe is ALD403?
Not only did ALD403 meet the key efficacy endpoints, but it also emerged with a clear safety profile. The biotech said that no patients demonstrated safety signals that would cause discontinuation in the development of the drug as a marketable product.
According to Alder CEO Randall C. Schatzman, there are plans for two additional clinical trials of the compound before they file a regulatory submission.