Teva is discontinuing a late-stage trial assessing the efficacy of its experimental anti-CGRP therapy fremanezumab in reducing cluster headaches.
The drugmaker said a planned futility analysis of the trial, part of the ENFORCE Phase III clinical development programme, showed that the primary endpoint of reducing the monthly average number of cluster headache attacks during the 12-week treatment period was unlikely to be met.
On the plus side, there were no safety concerns observed with fremanezumab treatment in the study, the firm stressed.
The trial assessing the drug’s efficacy in reducing episodic cluster headache is not affected and continues 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,” said Tushar Shah, head of global specialty clinical development at Teva.
Fremanezumab is currently under review in the US, with an action date of September 16, and in Europe, as a quarterly or monthly injection for the preventive treatment of migraine in adults.