Teva Pharmaceuticals’ investigational treatment for migraine prevention, fremanezumab, was able to statistically significantly reduce the number of monthly headache days in patients suffering from chronic migraines. These positive, top-line results from the Phase III HALO CM clinical trial were observed in both the monthly and quarterly dosing regimens.
“Migraine is a serious, debilitating neurological condition that substantially impacts all aspects of a person’s life,” said Dr. Michael Hayden, 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.”
The Phase III HALO EM clinical trial recruited 1,130 patients for a 16-week study. Patients were randomly assigned to one of three groups: monthly dosing of fremanezumab, quarterly dosing or a placebo.
Patients treated with the investigational migraine drug experienced a reduction of 2.5 headache days of at least moderate severity, compared to the placebo group. In addition to meeting this primary endpoint, patients taking fremanezumab saw significant improvements over the placebo on measures of response rate, onset of efficacy, efficacy as monotherapy and disability.
Teva notes that patients already taking prophylactic medications to prevent migraines were included in the study. As the biologic drug is an injectable, they report that injection site pain was a common adverse event in the treatment groups as well as in those taking the placebo.
Fremanezumab is a monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor, which is thought to be involved in the pathology of migraines. Since it’s estimated that over 38 million Americans suffer from migraines and there are few treatments approved to treat the condition, fremanezumab could fill an unmet need if approved.
“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 Dr. Marcelo Bigal, Chief Medical Officer & Head of Specialty Clinical Development at Teva. According to Teva, the results of this clinical trial will be used to support a Biological License Application for fremanezumab, to be submitted to the FDA later this year.