Teva Pharmaceutical has announced positive findings from the exploratory endpoint analysis of the Phase IIIb FOCUS clinical trial that evaluated fremanezumab as a preventive therapy for migraine in adults.
Fremanezumab is a humanised monoclonal antibody that binds to and prevents the interaction of calcitonin gene-related peptide (CGRP) ligand with its receptor.
The FOCUS study assessed the safety, efficacy, and tolerability of quarterly and monthly fremanezumab therapy in episodic or chronic migraine patients who did not achieve adequate response to two to four classes of preventive drugs.
Teva’s drug was compared to placebo in the multi-centre, randomised, double-blind, parallel-group, placebo-controlled trial.
Data for exploratory endpoints showed a clinically meaningful decrease in the monthly average migraine days, while ≥50% response rates were sustained over three months and were significantly greater in patients treated with fremanezumab.
A monthly and quarterly regimen of the drug minimised migraine-related symptoms of nausea or vomiting and photophobia and phonophobia versus placebo.
Both dosing regimens also led to greater reductions from baseline in the disability score in patients treated with fremanezumab.
Results further showed improvements in quality of life and health status of participants in the active drug arm. Mean changes in quality of life were reported four weeks after the third dose.
Subjects on monthly fremanezumab also experienced improvements in depression status, compared to placebo. However, the improvements were at a lesser degree with quarterly dosing.
Teva’s medication demonstrated greater improvements from baseline in work productivity and activity impairment during the four weeks after the third dose.
Both dosing regimens were found to significantly minimise the use of acute headache medication.
Teva Migraine & Headache global medical lead Joshua Cohen said: “Data from the FOCUS study disclose the results of fremanezumab on a range of quality of life and disability measures, as well as demonstrating a significant reduction in the number of headache hours and days suffered by patients and on a spectrum of associated symptoms.”
In April this year, the Israeli company revealed plans to suspend the ENFORCE Phase III clinical development programme of fremanezumab in cluster headache following futility analysis.