Teva Pharmaceuticals announced the clinical development program for the use of fremanezumab in cluster headaches will be discontinued. This decision follows a pre-specified futility analysis of a Phase III study in episodic cluster headache, which revealed that the study’s primary endpoint of mean change from baseline in the weekly average number of cluster headache attacks during the 4-week treatment period is unlikely to be met.
Based on the analysis, Teva is discontinuing the ENFORCE Phase III clinical trial program, which also includes a long-term safety study. The program previously included a chronic cluster headache study, which was discontinued in June of 2018.
Teva will continue to evaluate other indications for fremanezumab, including the treatment of post-traumatic headache which is currently being studied in a Phase II trial.
The FDA approved fremanezumab in September of 2018 for migraine prevention. It is marketed under the brand name Ajovy.
About Cluster Headaches
Cluster headache is a rare primary headache disorder that consists of severe headaches on one side of the head associated with red or teary eyes, runny or stuffy nose, flushing or sweating of the face or a sense of restlessness and agitation. The term cluster headache comes from the recurrence of headache attacks usually in a series (cluster periods) lasting for weeks or months, separated by remission periods (periods of headache freedom) usually lasting months or years.
Fremanezumab is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and prevents it from binding to the receptor. Patients experiencing migraine have increased levels of CGRP, a neuropeptide present in both the central and peripheral nervous system. When CGRP binds to its receptor, a cascade of events results, which contributes to neurogenic inflammation that is associated with migraine pain. Fremanezumab selectively targets the CGRP ligand, which is believed to block this cascade of events, thereby preventing the activation of the trigeminal system.