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 for migraine prevention. The data, presented at the American Headache Society’s 61st Annual Scientific Meeting, underscores eptinezumab's potential to offer clinically meaningful improvements for migraine sufferers.
Key Findings:
- PROMISE-1 Trial: 18.1% of episodic migraine patients treated with 100 mg of eptinezumab and 25.2% with 300 mg experienced no migraine days for at least half of the study period, compared to 12.6% on placebo. Additionally, 63.3% and 64.4% of patients treated with 100 mg and 300 mg, respectively, achieved at least one migraine-free month over the one-year study period, versus 47.7% on placebo.
- PROMISE-2 Trial: 14.0% of chronic migraine patients treated with 100 mg and 19.1% with 300 mg of eptinezumab experienced no migraine days for at least half of the study period, compared to 4.9% on placebo. Moreover, 34.6% and 39.7% of patients treated with 100 mg and 300 mg, respectively, achieved at least one migraine-free month over the six-month study period, versus 22.4% on placebo.
Migraine Severity and Quality of Life:
A second post-hoc analysis within the PROMISE-2 trial evaluated eptinezumab's efficacy in reducing migraine severity, a significant factor affecting quality of life. The analysis showed that over half of eptinezumab-treated patients experienced a one-category decrease in the frequency of severe headaches by Month 1, compared to 43.7% for placebo. Eptinezumab treatment also resulted in clinically meaningful improvements in HIT-6 scores as early as Month 1, which were maintained or further improved throughout the study period.
Safety and Tolerability:
Safety and tolerability were evaluated across all eptinezumab clinical trials, with no serious adverse drug reactions related to eptinezumab identified. The U.S. Food and Drug Administration accepted the Biologics License Application for eptinezumab in April 2019, with a target action date of February 21, 2020. If approved, eptinezumab will be the first-to-market intravenous therapy for migraine prevention.
About Eptinezumab:
Eptinezumab is an investigational monoclonal antibody delivered via IV, designed for 100% bioavailability with high specificity and strong binding for suppression of calcitonin gene-related peptide (CGRP). Its potential approval by the FDA marks a significant advancement in migraine treatment, offering a new option for those seeking prevention.
