Pharmaceutical company Samumed has started enrolling patients in a Phase II trial of SM04690, a potential treatment for osteoarthritis (OA) of the knee.
The trial is designed to evaluate the safety, tolerability, and efficacy of SM04690 when injected in a target knee joint of moderately to severely symptomatic OA patients.
SM04690 is a small molecule inhibitor of the Wnt pathway.
Around 400 patients will be enrolled in the trial, which will study three different doses of SM04690 against a placebo.
The trial's results will be evaluated using pain and function subscores from the Western Ontario and McMaster Universities Osteoarthritis Index (Womac), as well as patient global assessment.
The Womac is used to assess the condition of patients with OA of the knee and hip, including pain, stiffness, and physical joint function.
Samumed chief medical officer Yusuf Yazici said: "The safety and the efficacy results of our Phase I trial encouraged us to move into a Phase II clinical trial."
The Phase II trial will examine changes in joint space width, which will be documented by radiographs of the target knee at weeks 26 and 52.
At next week's annual meeting of the American College of Rheumatology, the company will present preclinical results showing cartilage regeneration in an animal model of OA.
Samumed will also present the safety, pharmacokinetics, efficacy and imaging results (MRI and radiographs) from the Phase I trial of SM04690.