Teva and Regeneron Pharmaceuticals have unveiled positive topline results from a Phase III study assessing the safety and efficacy 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, the firm notes, with fasinumab-treated patients experiencing significantly less pain and significantly improved functional ability from baseline compared to placebo.
Change in pain versus baseline was -2.78 for those receiving 1mg every four weeks, -2.25 for patients receiving fasinumab 1mg every eight weeks, and -1.56 for those in the placebo arm.
The change in physical function at week 16 from baseline was -2.57, -2.10 and -1.37, respectively, further highlighting the drug’s potential.
Also of note, interim safety data indicate that the nerve growth factor inhibitor 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 percent of the placebo group patients, 5 percent of the fasinumab 1mg every eight weeks group patients and 6 percent of the fasinumab 1mg every four weeks group patients.
“We are encouraged by these data and look forward to advancing our pivotal Phase III fasinumab programme 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,” noted George Yancopoulos, Regeneron’s president and chief scientific officer.