Global pharmaceutical company Teva is to end a late-stage trial of fremanezumab for chronic cluster headaches. Its ENFORCE Phase III clinical development programme includes a chronic cluster headache study, an episodic cluster headache study, and a long-term safety study.
A pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period was unlikely to be met, Teva said [June 15 2018].
However, Teva stressed there were no safety concerns observed with fremanezumab treatment in the trial.
The episodic cluster headache study is not affected and will continue as planned.
Tushar Shah, senior vice president, head of global specialty clinical development at Teva 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.”
Fremanezumab is under review by the US Food and Drug Administration (FDA), with an action date of September 16, 2018, and by the European Medicines Agency (EMA), as a quarterly or monthly injection for the preventive treatment of migraine in adults.