Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced on 8/16/18 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 Phase III study compared two different dose schedules of fasinumab (1 mg injection every four or eight weeks) against placebo. Topline results showed that fasinumab provided significant improvement over placebo in both pain and physical function. Dosing fasinumab every four weeks showed a slight improvement vs dosing every 8 weeks.
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.
Fasinumab is an investigational therapy invented by Regeneron using the company's proprietary VelocImmune technology that yields optimized fully-human antibodies. Fasinumab targets nerve growth factor (NGF), a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in the synovial fluid of patients with chronic pain conditions.
Regeneron and Teva are currently enrolling patients with chronic pain caused by OA of the knee or hip in three Phase 3 clinical trials including one assessing fasinumab long-term safety and two trials comparing fasinumab to standard pain therapies.