PETAH TIKVA (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Teva Pharmaceutical Industries Ltd. (TEVA) announced Monday that the U.S. Food and Drug Administration has placed the Phase 2b fasinumab study in patients with chronic low back pain on clinical hold and requested an amendment of the study protocol.
In pre-market activity on Nasdaq, Regeneron shares were losing 1.79 percent at $365.01.
Fasinumab is an investigational Nerve Growth Factor or NGF antibody in clinical development for osteoarthritis pain and chronic low back pain.
The company noted that FDA's request for an amendment of the study protocol was 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.
Preliminary safety results are generally consistent with what has been previously reported with the class. The Phase 2b chronic low back pain study enrolled approximately 70 percent of the targeted 800 patients in four dose groups.
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 3 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.
Further, based on data from the fasinumab Phase 2/3 osteoarthritis pain study, the companies are planning to advance only lower doses in the ongoing fasinumab osteoarthritis pivotal Phase 3 program, subject to discussion with the FDA and other health authorities.
Updated data from the osteoarthritis pain Phase 2/3 study and the chronic low back pain Phase 2b study will be presented at upcoming medical congresses.
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.
Copyright RTT News/dpa-AFX