Positive Phase III data for migraine drug fremanezumab

Positive results from a Phase III HALO study of fremanezumab, an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody investigational treatment for the prevention of migraine, have been announced by Israel-based Teva Pharmaceutical Industries (NYSE: TEVA).

In the chronic migraine (CM) study, patients treated with fremanezumab experienced statistically-significant reduction in the number of monthly headache days of at least moderate severity versus placebo (-2.5 days) during the 12 week period after first dose, for both monthly (-4.6 days p<0.0001) and quarterly (-4.3 days p<0.0001) dosing regimens. Similar to the Phase II trials, both patients that were on monotherapy and stable doses of prophylactic medications were included in the trial.

In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability. The results were positive, and of 13 hierarchical comparisons, p was <0.0001 in 12 of them, being 0.0004 in the remaining. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.