Novartis has reported positive results from the Phase III STRIVE clinical trial of erenumab evaluated for the prevention of episodic migraines.
Erenumab is a fully human monoclonal antibody being developed to target the CGRP receptor that is reported to be involved in migraine activation.
During the trial, erenumab was found to have led to clinically meaningful and statistically significant differences for all primary and secondary endpoints.
The investigational candidate was also found to be well-tolerated with a safety profile comparable to that of placebo.
Including a total of 955 patients, the multi-centre, randomised, double-blind, placebo-controlled Phase III trial assessed the safety and efficacy of subcutaneous 70mg and 140mg doses of erenumab over 24 weeks.
The results indicated that 50% of subjects administered with a 140mg dose experienced a minimum of a 3.7-day decrease in their migraine days from the baseline of 8.3 days.
Novartis Drug Development global head and chief medical officer Vas Narasimhan said: “The results of the STRIVE study add to the evidence for the significant, consistent benefits of erenumab seen across the spectrum of chronic and episodic migraine, including patients who failed on previous preventive treatments.
“We are committed to bringing this much-needed treatment option to patients as soon as possible.”
The trial has also met various secondary study endpoints, including a reduction in the number of days using an acute or rescue migraine-specific medication per month, and decrease in physical impairment and the impact of migraines on daily activities.
More than 90% of subjects given erenumab are reported to have completed the trial, with only 2.2% of erenumab-treated patients and 2.5% in placebo arm discontinuing due to adverse reactions.