Regeneron and Teva announced positive topline results from a Phase 3 trial for fasinumab, an investigational treatment for patients with chronic pain associated with osteoarthritis of the knee or hip.
Fasinumab targets nerve growth factor (NGF), a protein that plays a central role in the regulation of pain signaling. In the Phase 3 study, participants were randomized to either subcutaneous fasinumab 1mg every 8 weeks (N=215), every 4 weeks (N=217), or placebo (N=214). Change in pain and physical function score from baseline were chosen as the co-primary endpoints.
Week 16 efficacy results showed that the change from baseline in pain (measured by the Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] pain subscale score) was -1.56, -2.25 (P=.0019), and -2.78 (P<.0001), for placebo, fasinumab every 8 weeks and fasinumab every 4 weeks, respectively.
Change in physical function at Week 16 vs baseline (measured by the WOMAC physical function subscale score) was -1.37, -2.10 (P=.0011), and -2.57 (P<.0001), respectively. Fasinumab was found to be well-tolerated with similar adverse events seen in previous trials.
“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 nonsteriodal anti-inflammatory drugs or opioids,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron.
Detailed results from the trial will be presented at an upcoming medical congress.
This article originally appeared on MPR