Alder BioPharmaceuticals, Inc. announced new data from post-hoc analyses of its PROMISE-1 and PROMISE-2 Phase 3 clinical trials for eptinezumab, an investigational monoclonal antibody developed for the prevention of migraine. Detailed data will be shared at the American Headache Society’s (AHS) 61st Annual Scientific Meeting in Philadelphia that further support eptinezumab’s clinical profile, including data on migraine-free months, migraine severity and quality of life. The 100% responder rate analyses evaluated the efficacy of eptinezumab in terms of the number of months a patient experienced no migraine days, i.e., the number of migraine-free months, during the one-year study period in the PROMISE-1 trial (four doses of eptinezumab, one every 12 weeks) and the six-month study period in the PROMISE-2 trial (two doses of eptinezumab, one every 12 weeks). At baseline, patients enrolled in PROMISE-1 were experiencing 8.6 mean monthly migraine days per month and patients in PROMISE-2 were experiencing 16.1 mean monthly migraine days per month. Post-hoc analyses were conducted that quantified the number of patients who experienced no migraine days during each month (that is a consecutive 28-day period) in the trial study period. PROMISE-1: 18.1% of episodic migraine patients treated with 100 mg of eptinezumab and 25.2% of those treated with 300 mg of eptinezumab experienced no migraine days for at least half of the study period (=six months) compared with 12.6% of placebo-treated patients; 63.3% of episodic migraine patients treated with 100 mg of eptinezumab and 64.4% of those treated with 300 mg achieved at least one migraine-free month (over the entire one-year study period) compared to 47.7% of those on placebo. PROMISE-2: 14.0% of chronic migraine patients treated with 100 mg of eptinezumab and 19.1% of those treated with 300 mg of eptinezumab experienced no migraine days for at least half of the study period (=three months) compared with 4.9% of placebo-treated patients; 34.6 % of chronic migraine patients treated with 100 mg of eptinezumab and 39.7% of those treated with 300 mg achieved at least one migraine-free month (over the entire six-month study period) compared to 22.4% of those on placebo; About twice as many patients with chronic migraine were 100% responders with eptinezumab than with placebo during any given month of the trial. A second post-hoc analysis examined eptinezumab’s efficacy in reducing migraine severity, which is a significant contributor to reduced quality of life and increased burden of disease. In the PROMISE-2 trial for chronic migraine, impact scores as measured by the Headache Impact Test (HIT-6) were significantly elevated at baseline. The analysis, conducted within PROMISE-2, evaluated the efficacy and related functional and health-related quality of life outcomes of eptinezumab in those patients enrolled in the trial who, during a screening, reported very often or always experiencing severe headaches (64.7%) per HIT-6. Efficacy endpoints that were evaluated included: change from baseline in HIT-6 total score and frequency of severe pain during headaches, as well as change from baseline in the 36-item Short-Form Health Survey (SF-36), which is a general measure of health-related quality of life.