Fremanezumab reduced chronic migraine headache day rates.
An investigational treatment designed to prevent migraines has returned positive results in a Phase III trial.
Fremanezumab, from Jerusalem-based Teva Pharmaceutical Industries, significantly reduced the rate of monthly moderate-severity headache days versus placebo in patients undergoing a 16-week trial, in both monthly and quarterly dosing regimens.
Patients treated with fremanezumab also experienced significant improvements in response rate, onset of efficacy, efficacy as monotherapy, and disability — all secondary endpoints in monthly and quarterly dosing regimens — versus placebo.
A total of 1,130 patients were randomized into 3 nearly equivalent groups. One group received subcutaneous injections of 675 mg fremanezumab, followed by a monthly 225 mg dose regimen for 2 months.
Another group received 675 fremanezumab at ignition, followed by placebo for 2 months at a quarterly dose regimen. The final group received 3 monthly doses of matching placebo.
The study included a screening visit, 28-day run-in period, and a 12-week treatment period, including a final evaluation at week 12 — 4 weeks after the final dose of study drug. The primary efficacy endpoint of the CM study was the mean change from baseline in the monthly average number of moderate-severity headache days during the 12-week period after the first dose of treatment.
The Phase III HALO study for the potential CM treatment followed its Phase II trial regimen with patients both on monotherapy and stable doses of prophylactic medications included in the trial. It will be proceeded by a similar Phase III HALO trial for episodic migraine (EM) treatment in the following weeks.
Teva Pharmaceutical officials praised the “top-line results” of the study. Marcelo Bigal, MD, PhD, Chief Medical Officer and Head of Specialty Clinical Development at Teva, said the results add to the growing body of evidence supporting the development of calcitonin gene-related peptide (CGRP) blockers for migraine treatment.
Increased CGRP levels have been documented in migraine patients over the years, with the short amino acid chain playing a major role in the pathophysiology of migraines.
The chronic condition is a serious and debilitating neurological condition that impacts all aspects of a patient’s life, Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva, said.
“Our Phase III clinical trial program has exhibited extremely encouraging results, including with a quarterly dosing regimen, for fremanezumab in chronic migraine,” Hayden said. “We are grateful to the patients and clinical investigators who participated in this study and helped to advance our understanding of the potential of fremanezumab as a preventive treatment option for the millions of people suffering from migraine.”
Officials also expressed excitement for sharing the data in public forums and gatherings in the following year. Teva intends to submit a Biologics License Application to the US Food and Drug Administration (FDA) for fremanezumab later this year.
Teva will also publish their Phase III fremanzumab study results for EM treatment in the coming weeks.
A press release regarding the trial was made available.