Teva axes Phase 3 trial into chronic cluster headache

With the advent of another week, there’s another trial discontinuation in the industry as Teva announces its decision to terminate further research into its calcitonin gene-related peptide (CGRP)-targeting monoclonal antibody fremanezumab for the treatment of chronic cluster headache after it became clear the drug is unlikely to hit its primary endpoint.

Specifically, a pre-specified futility analysis made it apparent that fremanezumab will not improve the mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period. No safety concerns were observed, however.

The Israeli company confirmed that plans for concurrent research into the drug’s efficacy in episodic cluster headache will not be affected and will continue as planned.

"While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine, where calcitonin gene-related peptide (CGRP) plays a contributory role in their pathophysiology," commented Dr Tushar Shah, Senior Vice President, Head of Global Specialty Clinical Development at Teva. "We would like to thank the patients and investigators for their participation in the Chronic Cluster Clinical Trial."

Fremanezumab is currently awaiting regulatory decisions from the EMA and FDA for the preventative treatment of migraine in adults.