With these patient-reported improvements in pain and function, as well as medial joint space widths, the next step is to begin Phase 3 clinical trials. Slated for the first part of 2019, these Phase 3 trials will continue studying patient reported outcomes and potential disease modification.
Practice Implications
In previous investigations of SM04690, improvement after a single injection was seen in patients between five and 12 weeks, with benefits lasting 6 months for some patients and 12 months for other patients.
“This [aspect] is very beneficial in practice to be able to give a patient a single injection that lasts for months, without returning for subsequent short-term injections, having to worry about taking oral medications or needing to address contraindications associated with commonly used pain relievers, such as steroid injections, NSAIDs or opioids,” Dr. Yazici says.
So far, research on the treatment has been limited to single painful knee OA. Dr. Yazici hopes long-term findings in OA patients with multiple joints involved can garner similar positive results. “Ultimately, the goal is to modify disease and improve patient pain and function to the point [at which] joint replacement may be unnecessary.”
Carina Stanton is a freelance science journalist based in Denver.
References
- Yazici Y, McAlindon TE, Gibofsky A, et al. Efficacy and safety from a phase 2b trial of SM04690, a novel, intra-articular, Wnt pathway inhibitor for the treatment of osteoarthritis of the knee [abstract]. Arthritis Rheumatol. 2018 Oct;70(suppl 10).
- Yazici Y, McAlindon TE, Gibofsky A, et al. Results from a 52-week randomized, double-blind, placebo-controlled, phase 2 study of a novel, intra-articular wnt pathway inhibitor (SM04690) for the treatment of knee osteoarthritis. Osteoarthritis Cartilage. 2018 Apr;26(suppl 1):S293–S294.
- Yazici Y, McAlidon TE, Fleischmann R, et al. A novel Wnt pathway inhibitor, SM04690, for the treatment of moderate to severe osteoarthritis of the knee: Results of a 24-week, randomized, controlled, phase 1 study. Osteoarthritis Cartilage. 2017 Oct;25(10):1598–1606.
