Teva Pharmaceutical Industries Ltd. reported positive results from a phase 3 study evaluating TEV-48125 for the prevention of chronic migraine.
TEV-48125, or fremanezumab, is a fully humanized monoclonal antibody targeting the CGRP ligand, a well-validated target in migraine.
The study met its main goal of a statistically significant reduction in the number of monthly headache days of at least moderate severity compared to placebo during the 12-week period after first dose, for both monthly and quarterly dosing regimens.
In addition, the trial met its secondary endpoints for both dosing regimens, including response rate, onset of efficacy, efficacy as monotherapy and disability. The most commonly reported adverse event was injection site pain, with similar rates in the placebo and active groups.
Teva plans to submit a biologics license application to the U.S. FDA for the investigational treatment later in 2017.