Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Regeneron have announced that the US Food and Drug Administration (FDA) has suspended a Phase IIb fasinumab study in patients with chronic low back pain. Fasinumab is an investigational Nerve Growth Factor (NGF) antibody in clinical development for osteoarthritis pain and chronic low back pain.
The FDA has placed the study on clinical hold and requested an amendment of the study protocol after observing a case of adjudicated arthropathy in a patient receiving high dose fasinumab who had advanced osteoarthritis at study entry. As a result of the FDA decision, Regeneron completed an unplanned interim review of results and has stopped dosing in the study.
This latest development comes less than a month after Teva paid Regeneron $250 million for half of the rights of fasinumab outside of Japan, Korea and other Asian countries.
Previously, the unplanned analysis showed clear evidence of efficacy with improvement in pain scores in all fasinumab groups compared to placebo at the 8- and 12-week time points. Preliminary safety results are generally consistent with what has been previously reported with the class. The Phase IIb chronic low back pain study enrolled 70% of the targeted 800 patients in four dose groups: placebo, 6mg subcutaneously monthly, 9mg subcutaneously monthly and 9mg intravenously every two months. Regeneron has notified health authorities and study investigators about the decision. Patients will continue to be followed for up to 36 weeks.
Based on these results, Regeneron and Teva plan to design a pivotal Phase II study in chronic low back pain that excludes patients with advanced osteoarthritis. The companies plan to submit a pivotal program plan for review with the FDA and other health authorities.
Teva president of global R&D & CSO Dr. Michael Hayden said, “We believe fasinumab represents an important potential innovation for patients with osteoarthritis pain and chronic low back pain who currently have clear unmet need and limited treatment options. We look forward to advancing clinical development for this promising novel therapy.”
Regeneron and Teva are collaborating on the global development and commercialization of fasinumab. Under a separate agreement with Regeneron, Mitsubishi Tanabe Pharma has exclusive development and commercial rights to fasinumab in Japan, Korea and nine other Asian countries.
Published by Globes [online], Israel business news - www.globes-online.com - on October 18, 2016
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