Teva Pharmaceutical Industries has announced a change in the ENFORCE Phase III clinical development programme of monoclonal antibody fremanezumab in chronic cluster headache.
A chronic cluster headache study, an episodic cluster headache study, and a long-term safety study are part of the new programme.
Following a pre-specified futility analysis of the chronic cluster headache study, it was found that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met.
During the trial, no safety concerns were observed with fremanezumab treatment.
Teva Pharmaceutical Industries senior vice-president, Global Specialty Clinical Development head Tushar Shah said: “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.
“We would like to thank the patients and investigators for their participation in the Chronic Cluster Clinical Trial.”
Based on the study meeting the futility criteria, the company said it will discontinue the trial for chronic cluster headache.
Patients participating in the long-term safety study will also discontinue their participation. However, the episodic cluster headache study, which is not affected, will continue as planned.
The US Food and Drug Administration (FDA) is currently reviewing fremanezumab, with an action date of 16 September.
It is also being reviewed by the European Medicines Agency (EMA), as a quarterly or monthly injection for the preventive treatment of migraine in adults.