Teva Pharmaceutical Industries said today it will halt a Phase III trial of fremanezumab (TEV-48125) for chronic cluster headaches, after concluding that the study is unlikely to meet its primary endpoint of a reduced number of headaches.
Teva said it is ending the chronic cluster headache trial (NCT02964338) after a prespecified futility analysis showed that fremanezumab was unlikely to meet the study’s primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period.
The study, which has an estimated enrollment of 300 participants, is designed to assess the efficacy and safety of two dose regimens of fremanezumab—intravenous/subcutaneous and subcutaneous—compared with placebo. The trial had an estimated primary completion date of October 9 and a full completion date of November 6.
In addition, Teva said it was halting enrollment in its 68-week ENFORCE safety study (NCT03107052), an enrollment-by-invitation assessment of fremanezumab in chronic cluster headache patients.
“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,” Tushar Shah, M.D., Teva SVP, head of Global Specialty Clinical Development, said in a statement.
Chronic cluster headaches would have been an add-on indication for fremanezumab, which is under FDA review for prevention of migraines. After Teva submitted its Biologics License Application (BLA) for the drug to the FDA, the agency initially set a target date for a decision on Teva’s under the Prescription Drug User Fee Act (PDUFA) of June 16. Teva gained expedited review by acquiring a priority review voucher
Last month, however, Teva confirmed that the FDA pushed back fremanezumab’s PDUFA date to September 16. The delay followed manufacturing issues. In February, Teva disclosed that Celltrion, the manufacturer of the drug’s active pharmaceutical ingredient, received an FDA warning letter for its facility in Incheon, South Korea. Celltrion told Reuters in April it was working to address the undisclosed manufacturing issues raised by the agency.