The investigational drug SM04690 is a small molecule inhibitor of the Wnt pathway.
The approximately 400 patient trial will study three different doses of SM04690 against a placebo, with 100 patients in each arm. The primary outcome measures for the study are change from baseline as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function subscores at Week 13, as well as patient global assessment during the same time period.
The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of patients with OA of the knee and hip, including pain, stiffness, and physical function of the joints.
In addition, the trial will study change from baseline in joint space width (i.e., the distance between the two bones in the target knee) as documented by radiographs (x-ray) of the target knee at Weeks 26 and 52.
Samumed chief medical officer Yusuf Yazici said: "Both the safety and the efficacy results of our Phase I trial encouraged us to move into a Phase II clinical trial."