Alder Biopharmaceuticals has recently released follow up data to their Phase 2b clinical trial investigating the efficacy of a new, preventative migraine drug, ALD403. Results of the trial were initially released at the 12-week point in March 2016, and Alder has just released the 24-week results, ahead of their final follow-up after 48-weeks, the completion of the study.
The study was double-blind and placebo-controlled, where randomized groups of approximately 120 patients each received ALD403 in either 10 mg, 30 mg, 100 mg, or 300 mg doses intravenously. A final group of approximately 120 patients, also with chronic migraine, received a placebo intravenously. ALD403 is an antibody made by Alder that is a CGRP-target (calcitonin gene-related peptide). The primary efficacy endpoint of the study was to observe a 75% reduction in migraine days for those with chronic migraine over a 12-week period, with a secondary goal of observing a mean reduction in migraine days from baseline. Results were promising at the end of the 12-week period, but have since been strengthened by results at the 24-week mark.
At the 12-week mark, 33% and 31% of patients who received a single intravenous dose of 300 mg and 100 mg ALD403, respectively, met the primary endpoint of 75% reduction in migraine days and a significant reduction in mean migraine days over baseline as a whole. After 24 weeks, these numbers stayed fairly consistent, at 29% and 31% of individuals who received the 100 mg and 300 mg dose levels reporting a 75% reduction in migraine days. This results shows incredible promise for a long-lasting one time administered migraine drug.
The study was part of Alder’s PROMISE 1 (Prevention of Migraine via Intravenous ALD403 Safety and Efficacy 1) initiative, and results will be reported again at the 48-week mark, which will conclude the study. The results from all three checkpoints will inform and guide researchers as they begin the PROMISE 2 initiative, and work towards getting ALD403 on the market.
“The 24-week data confirm and extend our previously reported 12-week data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group. These data will help us finalize the dose selection and design of PROMISE 2, our second planned pivotal trial on track to start later this year. Additionally, the data validate the dose selection for the ongoing PROMISE 1 study and further demonstrate ALD403’s best-in-class potential as evidenced by prolonged migraine prevention after a single injection. Reinforced by these positive results, we will continue to advance our development plan and, assuming regulatory approval, commercialize ALD403 in the U.S. to meet the needs of the approximate 13 million Americans who are candidates for a migraine preventative therapy.”-Randall C.
Schatzman, Ph.D. and president and chief executive officer of Alder.
There were no additional safety findings at the 24-week mark, and while some promise was observed at the 30 mg dose level, the 10 mg dose level did not show significant results. More information on additional secondary endpoints, ALD403, and any other findings should be coming to light at upcoming conferences and peer-reviewed medical journals.