Bone Therapeutics completed recruitment and treated more than 700 patients in its pivotal Phase III clinical study with the JTA-004 viscosupplement in patients with knee osteoarthritis (OA).
First patients were treated in May 2020. Topline results are anticipated on the three-month primary endpoint and six-month follow-up period in 3Q21.
The controlled, randomized, double-blind trial is evaluating the potential of a single, intra-articular injection of JTA-004 to reduce OA pain in the knee up to 12 months, compared to placebo or Hylan G-F 20 (Synvisc).
JTA-004 is a blend of hyaluronic acid and a fast-acting analgesic intended to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a previous randomized, double-blind Phase II study involving 164 patients, JTA-004 showed superior clinical benefit with an improved pain relief at three and six months compared to Hylan G-F 20.
“The Covid-19 pandemic has had a substantial impact on the progress of clinical studies globally. As a result, Bone Therapeutics successfully completing patient recruitment of this large clinical study, evaluating more than 700 patients, on time and schedule, is a tremendous achievement. The contribution of patients, clinicians, clinical study operators has been invaluable to achieving this major milestone." - Olivier Godeaux, Chief Medical Officer of Bone Therapeutics