Regeneron and Teva Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip

Regeneron Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary efficacy analysis, the study met both co-primary endpoints and all key secondary endpoints. Fasinumab-treated patients experienced significantly less pain and significantly improved functional ability from baseline compared to placebo.

“We are encouraged by these data and look forward to advancing our pivotal Phase 3 fasinumab program in patients with osteoarthritis of the knee or hip, who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steriodal anti-inflammatory drugs or opioids,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.

The study compared two different fasinumab treatment arms (subcutaneous 1 mg every four or eight weeks) with placebo. The co-primary endpoint results are presented in Table 1.

Table 1: Topline Efficacy Results from Phase 3 Study¹

1. Approximately 85% of sub-study patients had OA of the knee; 2. As measured by the Western Ontario and McMaster Universities Osteorarthritis Index (WOMAC) pain subscale score (score range: 0-10); 3. As measured by the WOMAC physical function subscale score (score range: 0-10)

After the primary efficacy assessment at week 16, patients continue on therapy for an additional 36 weeks, followed by a subsequent 20-week off study drug follow-up period for further safety assessment.

Interim safety data indicate that fasinumab was generally well tolerated, with similar adverse events (AEs) as those observed in previous fasinumab trials. At week 16, treatment discontinuations due to AEs had occurred in 6% of the placebo group patients, 5% of the fasinumab 1 mg every eight weeks group patients and 6% of the fasinumab 1 mg every four weeks group patients. The fasinumab safety program was designed to capture all arthropathies (joint damage), including those identified due to symptoms and those identified by regularly-scheduled radiographic monitoring, the first of which was scheduled at week 24. Among the approximately 65% of patients who had completed their first radiographic assessment, the placebo-adjusted rate of adjudicated arthropathies was approximately 2%. The majority of arthropathies were captured by the regularly-scheduled radiographic monitoring and involved isolated joint space narrowing, called RPOA-1 (rapid progressive OA type 1). No cases of osteonecrosis have been identified to date in this study.

The companies plan to present detailed results at an upcoming medical congress.

Regeneron and Teva are jointly developing fasinumab as part of a global collaboration agreement. In Japan and 10 other Asian countries, Mitsubishi Tanabe Pharma Corporation holds exclusive development and commercial rights for fasinumab.