An analysis of the Phase III study in episodic cluster headache revealed that the study’s primary endpoint is unlikely to be met.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced that it is discontinuing its clinical development program for use of fremanezumab in cluster headaches. An analysis of the Phase III study in episodic cluster headache revealed that the study’s primary endpoint is unlikely to be met.
Consequently, Teva is abandoning 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 2018. Teva says it will continue to explore other uses for fremanezumab, including the treatment of post-traumatic headache (currently being studied in a Phase II trial).
Teva SVP head of global specialty clinical development Tushar Shah said, "We’d like to thank the patients and investigators for their immense contributions to this study. Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases where anti-calcitonin gene-related peptide (CGRP) therapy may play a role in its pathophysiology."
Published by Globes, Israel business news - en.globes.co.il - on April 23, 2019
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Teva Photo: Sivan Faraj