This article is more than 5 years old. Information may no longer be current.
Migraine prevention drug moves forward in development
Alder BioPharmaceuticals recently announced that eptinezumab, its candidate for preventing migraines, met primary endpoints in a phase 3 trial.
“If approved, eptinezumab will be the first and only [anti-calcitonin gene-related peptide] delivered by quarterly infusion, which results in 100% bioavailability,” Randall C. Schatzman, PhD, president and CEO, Alder BioPharmaceuticals, told Healio Family Medicine.
The company stated in a press release that the phase 3, double-blind, randomized, placebo-controlled global PROMISE 2 trial consisted of 1,072 patients who had 15 or more headache days per month, of which at least eight would be considered a migraine. These patients received an infusion of either 100 mg or 300 mg of eptinezumab or placebo once every 12 weeks.
According to Alder Biopharmaceuticals, eptinezumab met the primary endpoint of 8.2 fewer monthly migraine days from baseline vs. placebo (P < .0001). Responder rates for months 1 through 3 were: 61% of patients receiving eptinezumab reached 50% or greater reduction in migraine days from baseline vs. 39% for placebo; 33% of patients receiving eptinezumab reached a 75% or greater reduction in migraine days from baseline vs. 15% for placebo; 15% of patients receiving eptinezumab did not have any migraines for 3 full months vs. 5% for placebo; and, for what the company called Rapid Day One prevention, a 52% reduction in risk for migraine starting at day 1 postinfusion vs. 27% for placebo (P for all < .0001).
The release also stated that adverse events included nasopharyngitis (6.3%), upper respiratory infection (4%), nausea (3.4%) UTI (3.1%), dizziness (2.6%), arthralgia (2.3%), and anxiety and fatigue (2% each). These rates were similar in both treatment groups.
“The observed safety profile in PROMISE 2, to date, is consistent with previously reported eptinezumab studies... With these results, we remain on track to submit our biologics license application in the second half of 2018,” Schatzman said.
“If approved, eptinezumab has the potential to advance the treatment paradigm in migraine prevention and be a meaningful treatment option for millions of the most severely impacted patients with this debilitating disease,” he added.
Additional phase 3 studies to evaluate eptinezumab’s safety and efficacy in migraine prevention are underway, according to Alder Biopharmaceuticals. – by Janel Miller
Disclosure: Schatzman is president and CEO of Alder.