Bone Therapeutics announces it has commenced treating the first patients for the pivotal JTA 004 phase III clinical study in Hong Kong SAR. Several clinical trial sites in Europe are also expected to resume recruitment activities as COVID-19 lockdown measures are gradually being lifted.
The JTA 004 phase III study is a controlled, randomized, double-blind trial. It will evaluate the potential of a single, intra-articular injection of JTA 004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20, the leading current osteoarthritis treatment on the market. In the study, 676 patients with mild to moderate symptomatic knee osteoarthritis are expected to be enrolled. The study will be conducted in approximately 20 centers in six European countries as well as Hong Kong SAR. Bone Therapeutics has already received approval to start the JTA 004 phase III trial in five of the seven territories. It expects to obtain approval in the remaining two countries in the course of the next month.
Reporting of the topline results of the study on the 3-month primary endpoint and 6-month follow-up period is planned in the second half of 2021. Bone Therapeutics has noted that, despite lockdowns being lifted internationally, patient recruitment and the progress of the clinical trial could still be delayed with a change in the evolution of the COVID-19 pandemic..
JTA 004 is Bone Therapeutics’ next generation of intra-articular injectables for the treatment of osteoarthritic pain in the knee. Consisting of a unique mix of plasma proteins, hyaluronic acid – a natural component of knee synovial fluid, and a fast-acting analgesic, JTA 004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a phase II study involving 164 patients, JTA 004 showed an improved pain relief at 3 and 6 months compared to Hylan G-F 20, the global market leader in osteoarthritis treatment.