Positive Phase III confirmatory study of ONO-5704/SI-613 in patients with knee osteoarthritis in Japan

Positive top-line results have been released from a Phase III confirmatory study of ONO-5704/SI-613 in patients with knee osteoarthritis, one of the ongoing three Phase III clinical studies being jointly developed for the treatment of osteoarthritis in Japan by Ono Pharmaceutical (TYO: 4528) and Seikagaku Corp (TYO: 4548), with the news sending the latter’s share up 6.72% to 1,397 yen by close of trading today.

The Study is a randomized, double-blind, placebo-controlled, parallel-group comparative study in 440 patients with knee osteoarthritis. ONO-5704/SI-613 demonstrated a statistically-significant improvement in WOMAC (a knee pain evaluation index) scores, a primary endpoint of the Study, compared with a placebo at 12 weeks after the initial injection (three injections every four weeks). No major safety concerns were identified in the ONO-5704/SI-613 group.

Ono and Seikagaku will continue to proceed with the other two Phase III clinical studies and file an application for a manufacturing and marketing approval for ONO-5704/SI-613, aiming at the first half of 2020 after comprehensive evaluation on all data to be made available at the completion of all three studies.