Alder BioPharmaceuticals, Inc. announced new efficacy data highlighting consistency of early migraine prevention benefit across four clinical trials with eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) and is administered by quarterly infusion for migraine prevention. Detailed data will be presented at the 71st AAN Annual Meeting in Philadelphia, PA. Across the Phase 2 and Phase 3 clinical trials, it was observed that eptinezumab, facilitated by its 100% bioavailability at the end of infusion, showed a rapid onset of migraine prevention. The rapid response observed within Day 1 and Month 1 was sustained through the first quarter following infusion, maintained or further increased through subsequent infusions and consistent across four clinical trials. Safety and tolerability were evaluated in the eptinezumab clinical trials. No serious adverse drug reactions related to eptinezumab were identified within the clinical trial program. Highlights from the Phase 3 Early Relief Data include: Episodic Migraine: 52.3% reduction in the percentage of patients with a migraine on Day 1 in those treated with 100 mg eptinezumab and 54.9% in those treated with 300 mg eptinezumab compared to 24.5% for placebo. Chronic Migraine: 50.3% reduction in the percentage of patients with a migraine on Day 1 in those treated with 100 mg eptinezumab and 51.6% in those treated with 300 mg eptinezumab compared to 27.1% for placebo. The U.S. Food and Drug Administration (FDA) accepted Alder’s Biologics License Application (BLA) for eptinezumab in April 2019, with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2020. If approved, it will be the first quarterly, anti-CGRP infusion therapy for migraine prevention. PROMISE-1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-1) was a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for episodic migraine prevention. In the study, patients were randomized and 888 received eptinezumab (30 mg, 100 mg or 300 mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at most 14 headache days per month, of which at least four met the criteria for migraine. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week treatment period. Secondary study endpoints include at least 75% and at least 50% responder rates assessed through 12 weeks, and percentage of patients experiencing migraine on the day following administration. In June 2017, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE-1. PROMISE-2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-2) was a Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for chronic migraine prevention. In the study, patients were randomized and 1,072 received eptinezumab (100 mg or 300 mg) or placebo, administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at least 15 headache days per month, of which at least eight met the criteria for migraine. Patients that participated in the trial had an average of 16.1 migraine days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine days over the 12-week, double-blind treatment period. Secondary study endpoints included percentage of patients experiencing migraine on the day following administration and reduction of migraine prevalence days 1-28, reduction of at least 50%, 75%, and 100% from baseline in mean monthly migraine days assessed through 12 weeks, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in patient-reported impact scores on the Headache Impact Test (HIT-6). In January 2018, Alder announced that eptinezumab met the primary endpoint and key secondary endpoints in PROMISE-2. Safety and tolerability were evaluated in the eptinezumab clinical trials. The most common adverse reaction in the clinical trials for the preventive treatment of migraine (those with incidence at least 2% and at least 2% greater than placebo) was nasopharyngitis (swelling of the nasal passages and the back of the throat). No serious adverse drug reactions related to eptinezumab were identified within the clinical trial program.