Canadian biotechnology company, Eupraxia Pharmaceuticals, announced on Monday that it will move ahead with its late-stage development program after successfully achieving key targets in a clinical trial for its lead product candidate, EP-104IAR.
Promising Results in Phase 2b Clinical Trial
The Phase 2b clinical trial, which tested EP-104IAR for pain associated with knee osteoarthritis, produced positive results and met the primary endpoint by statistically and meaningfully improving pain relief after 12 weeks compared to the placebo. Additionally, EP-104IAR demonstrated significant improvement over the placebo for three out of four secondary endpoints at 12 weeks. Although the secondary endpoint measuring the difference in change from baseline in the WOMAC Pain subscale at 24 weeks was not met, statistical significance was achieved by week 14.
Positive Safety Data Found
Eupraxia Pharmaceuticals reported that the trial showed EP-104IAR to be well-tolerated, with adverse effects similar to those of the placebo, and no elevation of cortisol or blood glucose levels. The company added that it can use the safety data and its observed pharmacokinetic profile to develop a product that can be used for repeat and bilateral dosing, as well as in certain at-risk populations.
Fast-Track Designation Granted by the FDA
Earlier this month, it was announced that the U.S. Food and Drug Administration granted a fast-track designation for the investigation of EP-104IAR in treating adults with osteoarthritis of the knee.
Eupraxia Pharmaceuticals plans to continue and accelerate with its late-stage development program after this promising news.