Teva Pharmaceutical could gain an edge in the migraine treatment space due to new clinical data.
The Israeli drug company reported positive late-stage results for investigational therapy fremanezumab from a study with 1,130 people diagnosed with chronic migraine. People with the chronic condition suffer from 15 or more migraine days per months.
Fremanezumab is a monoclonal antibody targeting a protein called calcitonin gene related peptide (CGRP) linked to pain signaling.
Investigators conducted a 16-week randomized study designed to compare the safety, tolerability, and efficacy of four subcutaneous dosing regimens of fremanezumab against placebo. Patients either received subcutaneous injections of fremanezumab at 675 mg at the start followed by monthly 225 mg for two months (monthly dosing), fremanezumab at 675 mg at the start followed by placebo for two months (quarterly dosing), or three monthly doses of matching placebo, according to the official announcement.
Results indicated Teva’s candidate achieved its goals with the monthly and quarterly dosing regimens producing a statistically significant reduction in the number of monthly headache days of at least moderate severity compared to placebo.
The monthly regimen lowered the rate by 4.6 days whereas the quarterly one reduced it to 4.3 days.
“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, the Chief Medical Officer & Head of Specialty Clinical Development at Teva, in a statement.
Fremanezumab works similarly to rival drugs being developed by Amgen and Eli Lilly, but the success with different dosing regimens could help it stand out.
Results from an episodic migraine study will be presented in the next few weeks followed by a possible Biologics License Application submission to the U.S. Food and Drug Administration later this year.
Filed Under: Drug Discovery