Eli Lilly reports Emgality did not meet primary endpoint in CHALLENGE-MIG trial

Eli Lilly announced results of the CHALLENGE-MIG clinical trial of Emgality, a monoclonal antibody that inhibits the effects of CGRP by binding directly to CGRP, and Nurtec ODT, which it says is “the first and only trial of its kind” comparing two calcitonin gene-related peptide, or CGRP, antagonist therapies. Emgality did not meet the study’s primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days. Response rates were similar. However, it demonstrated clinically meaningful efficacy and safety in this 3-month study consistent with Emgality’s previous 6-month studies, and Emgality performed numerically better on key secondary endpoints of the 3-month trial, Eli Lilly stated. “These results bolster our knowledge of Emgality’s ability to work quickly and help patients improve their quality of life with less frequent dosing. Reducing the frequency of migraine headache days can help people experience more freedom from the burden of this debilitating neurological disease and get back to participating in the daily activities that matter most to them,” said Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience.