SM04690 worked in two doses to reduce pain and increase function in patients with osteoarthritis, according to recent study.

Biotech start-up Samumed is focused on advancing regenerative medicine by focusing on small-molecule drugs that modulate the Wnt pathway, which is a primary signaling pathway that regulates the self-renewal and differentiation of adult stem cells and is important for tissue formation, replenishment and repair. By modulating this pathway in select tissues, the company believes its drugs can recover and restore the health of diseased tissues.


As people age, their Wnt levels decrease, preventing the body from making enough of the right types of progenitor stem cells for certain tissues. Samumed has a pipeline of products targeting several conditions related to aging, such as hair regrowth for people who are going bald, the smoothing of wrinkles and the regeneration of cartilage in people suffering from osteoarthritis.

Most recently, the company announced that its osteoarthritis (OA) candidate SM04690 met its primary endpoints in a recent phase 2b trial. Patients with moderate to severe symptomatic knee OA treated with a single intra-articular knee injection of SM04690 demonstrated significant improvements in pain, function and patient global scores at two different doses. The trial involved 700 patients, lasted for 24 weeks and was a multi-center, randomized, double-blind, placebo-controlled study of four concentrations of SM04690. The drug was observed to exhibit three separate effects on joint health –– generation of cartilage, slowing down of cartilage breakdown and reduction of inflammation. 

According to Osman Kibar, CEO of Samumed. “The safety profile, the improvements in signs and symptoms, and the disease-modifying benefits of SM04690that we have observed in this phase 2b as well as earlier studies,are quite promising. We look forward to working with the FDA to take SM04690 into phase 3 pivotal trials, targeting a start date in early 2019.”