Teva is ending a phase 3 trial testing its calcitonin gene-related peptide (CGRP) blocker in chronic cluster headache after a futility analysis showed it was unlikely to meet its primary endpoint. While the drugmaker is exiting the cluster headache space, it remains in the CGRP game with two other indications.
Specifically, the analysis found that fremanezumab was not likely to meet the endpoint of mean change from baseline in the monthly average number of cluster headache attacks.
“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,” said Tushar Shah, M.D., who heads Global specialty clinical development at Teva.
Fremanezumab is in phase 2 for post-traumatic headache and is nearing an FDA decision for the treatment of migraine in adults. Its PDUFA date for the latter is Sept. 16. The phase 3 cluster headache program also included a study in episodic cluster headache, which was unaffected by the analysis and will continue.
Chronic cluster headache is proving to be a tough space. Teva's experience mirrors that of Eli Lilly and its CGRP medication galcanezumab—the treatment hit its primary endpoint in a phase 3 trial testing it in episodic cluster headache, but failed a phase 3 study in chronic cluster headache.
The drugmakers are competing in a crowded field that recently saw its first FDA nod—Amgen and partner Novartis got the injectable CGRP-blocking monoclonal antibody, Aimovig, past the agency in May. Most of the CGRP-targeting antibodies in development, including those from Teva, Lilly and Alder, are injectable, but Allergan and Biohaven are racing to get an oral version to market.
In April, Allergan's ubogeprant aced a second phase 3 trial for use in treating a single migraine of moderate-to-severe headache intensity, setting it up for an FDA filing in 2019. Biohaven's candidate is in phase 3, with an FDA submission scheduled for 2019.