BELGIUM – Bone Therapeutics has provided data update for its ongoing clinical studies on enhanced viscosupplement, JTA-004, targeting osteoarthritic knee pain.
The JTA-004 Phase III clinical study, having achieved target patient recruitment in December 2020, has now completed the six-month follow-up in all patients.
Bone Therapeutics expects to report topline results for the 3-month primary endpoint and 6-month follow-up data in the first half of September 2021.
JTA-004 Phase III study is a controlled, randomized, double-blind trial. It is evaluating the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee up to 12 months, compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market.
The study is being conducted in 22 centers across six European countries as well as Hong Kong. More than 700 patients have been treated. These patients fulfill all the strict protocol criteria including mild to moderate symptomatic knee osteoarthritis.
According to Research and Markets, the global osteoarthritis treatment market is projected to grow at a CAGR of 9.0%.
Osteoarthritis is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage that cushions the ends of your bones wears down over time.
However, osteoarthritis can damage any joint, the disorder most commonly affects joints in your hands, knees, hips & spine. There is an increase in risk of osteoarthritis as age increases.
According to OAFI Osteoarthritis Foundation International Osteoarthritis accounts for more than 500 million people affected worldwide.
Technologies have emerged in developed countries as North America & are spending about more than US$ 500 million for the research of arthritis.
Roughly a week ago, Active Implants, a developer of orthopedic implant solutions for joint preservation, announced two-year results of the MERCURY study.
Active Implants’ NUsurface Meniscus Implant provides statistically superior pain relief beginning at six months compared to non-surgical therapy.
The results were presented at the American Orthopedic Society for Sports Medicine-Arthroscopy Association of North America Combined 2021 Annual Meeting in Nashville.
NUsurface Implant is the first “artificial meniscus” to be marketed in Europe and is currently under review by the U.S. Food & Drug Administration (FDA).
The medial meniscus replacement mimics the function of the natural meniscus and treats pain by redistributing loads transmitted across the knee joint. It was granted a Breakthrough Device Designation from the FDA in 2019.
“The MERCURY study showed that patients who received the NUsurface Implant experienced statistically superior pain relief as early as six months that continued through the two-year study period, compared to patients receiving non-surgical care alone,” said Wayne Gersoff, M.D., a MERCURY investigator from Advanced Orthopedic & Sports Medicine Specialists in Denver, who presented the study results. “There is a significant need for new treatment options for patients who have persistent knee pain following a meniscectomy, which the NUsurface Implant may address.”