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.