Alder BioPharmaceuticals, Inc. has announced that eptinezumab, its lead product candidate for migraine prevention, successfully met the primary and key secondary endpoints in the PROMISE 1 Phase 3 pivotal clinical trial. This trial evaluated the efficacy and safety of eptinezumab in patients suffering from frequent episodic migraine.
Key Highlights from PROMISE 1:
- Primary Endpoint Achievement: The trial demonstrated highly statistically significant reductions in monthly migraine days.
- Day 1 Clinical Benefit: A significant reduction in the proportion of patients experiencing a migraine was observed on the first day post-dose.
- 75% Response Rates: Approximately one-third of patients achieved a 75% or greater reduction in migraine days through weeks 4 and 12.
- 100% Response: An average of one in five patients experienced no migraines in any given month over the first six months.
- Safety Profile: The safety profile of eptinezumab was similar to that of placebo, consistent with previous studies.
PROMISE 1 Top-Line Results:
- The primary endpoint showed a reduction in monthly migraine days from baseline over weeks 1 through 12, with significant results for both 300mg and 100mg doses compared to placebo.
- Secondary endpoints demonstrated improvements through the first and second quarterly dose periods, with a significant proportion of patients achieving a 75% reduction in monthly migraine days.
About Eptinezumab:
Eptinezumab is an investigational monoclonal antibody developed by Alder BioPharmaceuticals for the prevention of migraines. It is administered quarterly via infusion, targeting the calcitonin gene-related peptide (CGRP), a protein involved in migraine initiation.
About Migraine:
Migraine is a disabling neurological disease affecting millions worldwide, characterized by recurrent episodes of severe headache accompanied by nausea, vomiting, and sensitivity to light and sound. Current preventive treatments often fail to meet patient needs due to limitations in efficacy, safety, and tolerability.
Alder BioPharmaceuticals is committed to transforming the treatment paradigm for migraine patients, with eptinezumab representing a potential major advance in migraine prevention therapy. The company plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the second half of 2018, based on the results of PROMISE 1, PROMISE 2, and an open-label safety study.
