Teva Pharmaceutical has decided to suspend the ENFORCE Phase III clinical development programme of fremanezumab in cluster headache.
A futility analysis of a Phase III clinical trial for episodic cluster headache showed that the therapeutic is not likely to meet the primary endpoint of a mean change in the weekly average number of cluster headache attacks from baseline during the four-week treatment duration.
Based on the analysis of the results, Teva decided to suspend the clinical trial programme, which also includes a long-term safety study.
The programme also comprised a chronic cluster headache trial that was discontinued in June last year after a futility analysis found that the primary endpoint would not be met.
However, Teva intends to continue developing fremanezumab in other indications. The compound is currently being assessed in a Phase II trial to treat post-traumatic headaches.
Teva Pharmaceutical Global Specialty Clinical Development head Tushar Shah said: “Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases where anti-calcitonin gene-related peptide (CGRP) therapy may play a role in its pathophysiology.”
Fremanezumab is a humanised monoclonal antibody designed to bind to and prevent the calcitonin gene-related peptide (CGRP) ligand interaction with its receptor.
In September last year, the US Food and Drug Administration (FDA) approved the use of fremanezumab, under the brand name Ajovy, as a preventive treatment for migraine in adults.
The approval is based on data from two Phase III trials that assessed the drug as a stand-alone preventive therapy, as well as in combination with oral preventive treatments.
According to the results, patients had a decrease in monthly migraine days during a 12-week period.
