Alder has positive Phase 3 migraine trial results

Alder BioPharmaceuticals announced new six-month data from its PROMISE 2 Phase 3 clinical trial in patients with chronic migraine following a second quarterly infusion of eptinezumab. The data show that patients experienced a reduction of 8.8 monthly migraine days from baseline following the second quarterly infusion of 300 mg of eptinezumab. These results demonstrate a further numerical improvement in efficacy over the first infusion which resulted in a reduction from baseline of 8.2 MMDs in this trial. Eptinezumab is Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide. Highlights from PROMISE 2 Trial Following First and Second Infusions: After the first quarterly infusion, patients dosed with 300 mg of eptinezumab experienced 8.2 fewer MMDs, from a baseline of 16 MMDs, compared to 5.6 fewer MMDs for placebo from baseline. A further reduction in MMDs was seen following a second infusion; 8.8 fewer MMDs for patients dosed with 300 mg compared to 6.2 fewer MMDs for those with placebo. Approximately 21 percent of patients achieved, on average, 100 percent reduction of MMDs from baseline compared to 9 percent for placebo after two quarterly infusions of 300 mg of eptinezumab. 64 percent of patients achieved 50 percent or greater reduction of MMDs from baseline, compared to 44 percent for placebo; and 43 percent of patients achieved 75 percent or greater reduction of MMDs from baseline, compared to 24 percent for placebo after two quarterly infusions. There were no new safety findings observed with the second quarterly infusion. The observed safety profile for PROMISE 2, to date, is consistent with previously reported eptinezumab studies. Adverse event rates among eptinezumab-treated subjects were similar to placebo-treated subjects. The most commonly reported adverse events for eptinezumab, occurring at an incidence of 2.0 percent or greater and greater than placebo were: nasopharyngitis, urinary tract infection, nausea, arthralgia, dizziness, and fatigue

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