Though in very early stages, if clinical trials continue to show significant results, individuals living with knee osteoarthritis (OA) could have a knee injection treatment option that actually helps with cartilage growth in the knee.
Phase 1 research shared at the American College of Rheumatology (ACR) 2015 annual meeting in early November highlighted the potential an investigational joint injection referred to as SM04690 may have to slow down the symptoms of knee OA—the most common form of arthritis in the knee.
Targeting the source of knee pain
SM04690, developed by Samumed, LLC, is thought to inhibit Wnt signaling pathways, which control how different tissue cells, including bone and cartilage, regenerate. According to the company, overactive Wnt signaling in cells can cause an increase in spurious bone formation and reduce cartilage, which is associated with pain and loss of function in knee OA. In animal models, overactive Wnt signaling has also been shown to inhibit the growth of healthy cartilage in the knee.
At ACR 2015, Samumed presented preclinical data on the capacity of SM04690 to inhibit the Wnt pathway, therefore ”instructing” cells to form cartilage. In rat models of knee OA, the study found that a single injection of SM04690 grew cartilage in the knee joints.
According to a company press release, a 24-week placebo-controlled Phase 1 trial of 61 patients (49 taking SM04690; 12 taking placebo) was recently completed in patients with knee OA. It aimed to study the safety and preliminary efficacy of SM04690 in moderate to severe knee OA.
Initial results from the study were shared at ACR 2015:
- Preliminary safety and efficacy results suggested a single injection of SM04690 appeared to be safe and potentially effective in improving function as well as pain reduction for patients with knee OA. Of the 49 patients treated with SM04690, 22 experienced a total of 51 adverse events. Of the 12 patients in the placebo group, 6 experienced a total of 19 adverse events.
- Analysis of the imaging data showed a possible slowing or reversal of joint space narrowing in patients treated with SM04690 compared to placebo, although patient numbers were too small to make definite conclusions.
“The results of our Phase I study of SM04690 for the treatment of osteoarthritis of the knee are very encouraging,” said Yusuf Yazici, M.D., Chief Medical Officer of Samumed. “We believe that the clinical trial results we have seen to date, combined with the success of our animal results, demonstrate that our technology could potentially be the basis of a safe and effective treatment for the millions of patients suffering from osteoarthritis of the knee.”
The company currently is enrolling a 400 patient Phase 2 trial to investigate the safety and efficacy of this drug further. Please contact [email protected] for more information.