Samumed reports Phase II data for SM04690 in OA

Samumed LLC (San Diego, Calif.) reported interim data from the double-blind, U.S. Phase II SM04690-OA-02 trial in 455 patients with moderate to severe osteoarthritis (OA) of the knee showing that all 3 doses of SM04690 missed the primary endpoint of improving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore from baseline to week 13 vs. placebo. There were also no significant differences between any dose of SM04690 and placebo on the WOMAC pain subscore endpoint at weeks 26 and 39. Patients received a single intra-articular injection of placebo or 0.03, 0.07 or 0.23 mg SM04690.

All 3 doses of SM04690 also missed the secondary endpoint of improving WOMAC function subscore from baseline to week 13 vs. placebo. There were also no significant differences between SM04690 and placebo on the WOMAC function subscore endpoint at weeks 26 and 39...