Regeneron and Teva provide update on progress of Phase IIb trial of fasinumab to treat chronic low back pain.

Regeneron Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. provided an update on fasinumab, triggered by a recent development in 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 Phase IIb study in chronic low back pain 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.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 (nominal p less than 0.01). Preliminary safety results are generally consistent with what has been previously reported with the class. The Phase IIb chronic low back pain study enrolled approximately 70 percent 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 III 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.