A novel cathepsin K inhibitor, MIV-711, is no more effective than placebo for reducing pain in patients with symptomatic, radiographic knee osteoarthritis, according to a study published online Dec. 31 in the Annals of Internal Medicine.

Philip G. Conaghan, M.B.B.S., Ph.D., from the University of Leeds in the United Kingdom, and colleagues examined the efficacy, safety, and tolerability of MIV-711 in participants with symptomatic, radiographic knee osteoarthritis in a 26-week randomized, double-blind, placebo-controlled phase 2a trial with a 26-week open-label safety expansion. Patients received either MIV-711 100 mg daily (82 patients), 200 mg daily (81 patients), or matched placebo (77 patients). During the extension substudy, 46 patients who initially received 200 mg/day and four who received placebo received 200 mg of MIV-711 daily.

The researchers observed no significant changes in numerical rating scale pain scores with MIV-711 (placebo, −1.4; MIV-711 100 mg/day, −1.7; MIV-711 200 mg/day, −1.5). Significant reductions in medial femoral bone area progression and medial femoral cartilage thinning were seen for MIV-711 100 and 200 mg/day versus placebo; there were also substantial reductions noted in bone and cartilage biomarker levels. In six participants, there were nine serious adverse events; however, none were thought to be related to treatment.

"Further evaluation of MIV-711 in longer and larger trials to confirm the structural benefits observed here and whether these translate to more tangible benefits on symptoms is warranted," the authors write.

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