Positive Phase III Results Achieved for Migraine Prevention Regimens

Teva announces positive results for Phase III study of fremanezumab for the prevention of chronic migraine.

Teva Pharmaceutical Industries Ltd. announced positive results from a Phase III HALO study of fremanezumab, an investigational treatment for the prevention of migraine.

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 vs. 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.

“Migraine is a serious, debilitating neurological condition that substantially impacts all aspects of a person’s life,” said Michael Hayden, M.D., Ph.D., president of Global R&D and chief scientific officer at Teva. “Our Phase III clinical trial program has exhibited extremely encouraging results, including with a quarterly dosing regimen, for fremanezumab in chronic migraine. 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.”

“These top-line results reflect our differentiated clinical development program and add to a growing body of evidence that supports the development of CGRP targeted therapy in migraine, including patients with very severe forms of the disease, with flexible dosing regimens,” said Marcelo Bigal, M.D., Ph.D., chief medical officer and head of specialty clinical development at Teva.

“We are excited about our development progress and look forward to sharing more detailed results with the migraine community at future scientific conferences,” said Ernesto Aycardi, M.D., vice president and therapeutic area head, R&D, Migraine and Headache at Teva.

Based on these results, Teva plans to submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) for fremanezumab later this year. Teva’s Phase III HALO study in Episodic Migraine (EM) will report topline results in the coming weeks.

About the HALO Clinical Research Program

The Phase III HALO EM and CM studies are 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies to compare the safety, tolerability, and efficacy of four dose regimens of subcutaneous fremanezumab compared to placebo in adults with episodic and chronic migraine. The studies consist of a screening visit, a 28-day run-in period, and a 12-week (84-day) treatment period, including a final evaluation at week 12 (end-of-treatment [EOT] visit, four weeks [28 days] after the final dose of study drug).

In the CM study, 1,130 patients were randomized (around 376 patients per treatment group). Patients were randomized in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 675 mg at initiation followed by monthly 225 mg for two months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo.

The primary efficacy endpoint of the CM study was the mean change from baseline (28-day run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of fremanezumab.

(Source: Business Wire)