Teva discontinues cluster headache programme following futility analysis. Credit: Gerd Altmann from Pixabay.

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.

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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.

“Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases.”

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.”

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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.