Alder BioPharmaceuticals, Inc. announced a new analysis of patient-reported outcomes data from the PROMISE-2 Phase 3 clinical trial of eptinezumab for the prevention of chronic migraine. Eptinezumab is an investigational monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) administered by quarterly infusion for migraine prevention. The new analysis showed improvements in most bothersome migraine symptoms and patients’ global impression of change in their migraine status by Month 1 after treatment, with improvements sustained or increased through the first and second quarterly infusion. At Month 1 after treatment: 45% of patients treated with 100 mg of eptinezumab and 57% of patients treated with 300 mg of eptinezumab indicated their MBS was much improved or very much improved vs. 29% of patients receiving placebo; 45% of patients treated with 100 mg of eptinezumab and 59% of patients treated with 300 mg of eptinezumab indicated their PGIC was much improved or very much improved vs. 32% of patients receiving placebo; At Month 6, three months after the second quarterly infusion: 57% of patients treated with 100 mg of eptinezumab and 57% of patients treated with 300 mg of eptinezumab indicated their MBS was much improved or very much improved vs. 42% of patients receiving placebo; 60% of patients treated with 100 mg of eptinezumab and 60% of patients treated with 300 mg of eptinezumab indicated their PGIC was much improved or very much improved vs. 41% of patients receiving placebo; and Eptinezumab’s effect on a patient’s MBS was highly correlated with the patient’s impression of improvement in their overall migraine disease. The correlation was greater than what is observed with more standard measures such as mean monthly migraine days. The U.S. Food and Drug Administration accepted Alder’s Biologics License Application 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 infusion anti-CGRP 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 endpoints 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.