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Samumed Phase 2b Trial in Knee Osteoarthritis Meets Primary Endpoints
Pivotal phase 3 trials of SM04690 in knee osteoarthritis anticipated to begin early 2019
SAN DIEGO, Oct. 24, 2018 (GLOBE NEWSWIRE) -- Samumed announced today top-line data from its phase 2b trial of SM04690 in knee osteoarthritis (OA). Results showed that treatment with a single intra-articular injection of SM04690 demonstrated significant improvements in pain, function and patient global scores in two separate doses. Further details can be found here.
Samumed’s phase 2b trial was a 700-patient, 24-week, multi-center, randomized, double-blind, placebo-controlled study of four concentrations of SM04690, a Wnt pathway inhibitor, injected once intra-articularly into the target knee joint of subjects with moderately to severely symptomatic knee OA. Details of the study can be found here.
“The safety profile, the improvements in signs and symptoms, and the disease-modifying benefits of SM04690 that we have observed in this phase 2b as well as earlier studies, are quite promising,” said Osman Kibar, CEO of Samumed. “We look forward to working with the FDA to take SM04690 into phase 3 pivotal trials, targeting a start date in early 2019.”
About SM04690 and Osteoarthritis
SM04690 is a small molecule inhibitor of the Wnt pathway administered as an intra-articular injection and is being developed as a potential disease-modifying drug for osteoarthritis (DMOAD). SM04690’s mechanism of action exhibits three separate effects on joint health – generation of cartilage, slowing down of cartilage breakdown, and reduction of inflammation. There are currently no approved disease-modifying treatments for osteoarthritis. Additional information on Samumed’s SM04690 osteoarthritis program can be found here: https://www.samumed.com/pipeline/detail.aspx?id=20
Samumed’s small-molecule drug platform is harnessing the innate restorative power of the Wnt pathway to reverse the course of severe and prevalent diseases. Learn more about Samumed’s potential regenerative drug candidates and broad clinical pipeline at https://www.samumed.com/pipeline/default.aspx
Josephine Belluardo, Ph.D.
LifeSci Public Relations