Novel Small-Molecule Wnt Pathway Inhibitor Provides Significant Pain Relief for Knee Osteoarthritis

By Denise Baez

CHICAGO -- October 24, 2018 -- SM04690 provided significant pain relief, compared with placebo, among patients with knee osteoarthritis (OA), researchers reported here at the 2018 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).

A previous 52-week phase 2a study showed that SM04690 -- a novel small-molecule Wnt pathway inhibitor -- had positive effects on knee OA pain, physical function, and medial joint space width compared with placebo.

Yusuf Yazici, MD, Samumed, LLC, San Diego, California, and colleagues conducted the current phase 2b study to refine patient-reported outcome measures, target population, dose, and safety.

The study included 695 patients with ACR-defined knee OA. All patients had a pain numeric rating scale (NRS) of ≥4 and ≤8 on a 10-point scale in the target knee and <4 in the contralateral knee.

Patients received 1 intra-articular injection of 2 mL SM04690 (0.03, 0.07, 0.15 or 0.23 mg), vehicle placebo, or sham (dry needle only) to the target knee.

At week 12, there was significant improvements from baseline in pain NRS for the 0.07 mg dose (P = .001) and the 0.23 mg dose (P = .012). These improvements persisted until week 24 for both doses (P = .031 and P = .022, respectively).

Similar improvements were observed in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale for the 0.07 mg dose at week 12 (P = .04) and for the 0.23 mg dose at week 12 (P = .003) and week 24 (P = .031).

For WOMAC Physical Function, improvements were seen for the 0.07 mg and 0.23 mg dose at week 12 (P = .021 and P = .006, respectively) and week 24 (P = .017).

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

Funding for this study was provided by Samumed.

[Presentation title: 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. Late-Breaking Abstract 3]
Log in to post comments

Tell us what you think of DG News

Click to like Click to dislike