Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today provided an update that the Company is discontinuing the clinical development program for use of fremanezumab in cluster headaches. A pre-specified futility analysis of a Phase III study in episodic cluster headache 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.
As a result of the above, 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 continues to explore other uses for fremanezumab, including the treatment of post-traumatic headache (currently being studied in a Phase II trial).
“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,” said Tushar Shah, M.D., Senior Vice President, Head of Global Specialty Clinical Development at Teva.
Fremanezumab is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. Fremanezumab is considered an investigational compound in the treatment of cluster headache or post-traumatic headache and is not approved by any regulatory agency for those uses.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 35,000 products in nearly every therapeutic area. 200 million people around the world take a Teva medicine every day, served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
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Kevin C. Mannix, (215) 591-8912
Ran Meir, 972 (3) 926-7516
Doris Saltkill, (913) 777-3343
Yonatan Beker, 972 (54) 888 5898