US-based Amgen has reported positive top-line data from its Phase III ARISE Study of erenumab for the treatment of episodic migraines.
Jointly developed by Amgen and Novartis, Erenumab has been developed as a fully human monoclonal antibody specifically designed for migraine prevention.
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It is designed to target and block the calcitonin gene-related peptide (CGRP) receptor, considered to be instrumental in triggering migraines.
The Phase III multicentre, randomised, 12-week, double-blind, placebo-controlled ARISE trial was intended to test the safety and efficacy of erenumab in treating episodic migraines.
The study involved 577 patients who were randomised for a subcutaneous administration of erenumab and placebo on a once-monthly basis.
It was primarily focused on determining a baseline change induced by erenumab in monthly migraine days following a 12-week treatment phase.
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By GlobalDataThe study's secondary goals were to achieve at least a 50% reduction from baseline in monthly migraine days and change from baseline in monthly acute migraine-specific medication treatment days, determined on the basis of measurements done by the Migraine Physical Function Impact Diary (MPFID).
Results suggested the efficacy of erenumab through a significant reduction from baseline in monthly migraine days in patients with episodic migraine treated with erenumab.
Erenumab was also safe to be administered during the study.
Amgen research and development executive vice-president Sean Harper said: "People with episodic migraine lose a substantial part of their lives, and many face intolerable pain and physical impairment, frequently accompanied by a significant disruption of their daily activities.
“Unfortunately, there are limited preventive treatment options currently available for these patients.
"These positive results, along with the recent chronic migraine results, contribute to the growing body of evidence supporting erenumab as an innovative treatment option for people who are suffering from this debilitating disease."
Erenumab is currently undergoing several large global, randomised, double-blind, placebo-controlled trials to validate its safety and efficacy in preventing migraines.
