Seikagaku and Ono Announce Positive Study Results

By Julie A. Vetalice

Seikagaku and Ono Pharmaceutical obtained positive topline results from a Phase III confirmatory study of ONO-5704/SI-613 in the treatment of knee osteoarthritis (OA).

ONO-5704/SI-613 is a combination of hyaluronic acid (HA) and an NSAID to address pain and inflammation through a 3-injection regimen. Ono and Seikagaku formed a preliminary collaboration to co-develop and market the product in 2Q17, which became a definitive agreement later in the year.

Three Phase III studies are underway with the HA/NSAID formulation, including:

  • This confirmatory study in the knee
  • A study of OA in the shoulder, elbow, hip and ankle
  • A long-term study in OA patients to evaluate safety

This randomized, double-blind, placebo-controlled, parallel-group comparative study involved 440 patients with knee OA. ONO-5704/SI-613 demonstrated a statistically significant improvement in knee pain scores vs. placebo at 12 weeks after the initial injection, with no major safety concerns observed in the ONO-5704/SI-613 group. Ono and Seikagaku plan to file for manufacturing and marketing approval in 1H20, after evaluation of data from all three studies.

Sources: Seikagaku Corporation; ORTHOWORLD Inc.

Product Labels: Viscosupplement

Tags: Trial/Study