BONE THERAPEUTICS, the cell therapy company addressing unmet medical needs in orthopedics and other diseases, provides an update on its two leading ongoing clinical studies.
These studies are the pivotal Phase III clinical trial with Bone Therapeutics’ enhanced viscosupplement, JTA-004, targeting osteoarthritic knee pain, and the Phase IIb study with its allogeneic cell therapy product, ALLOB, in patients with difficult-to-heal tibial fractures.
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.
The Phase IIb ALLOB clinical study in high-risk tibial fractures is currently experiencing a delay in patient recruitment due to the COVID-19 pandemic and the associated containment measures. This delay is as a result of fewer accidents and reduced availability of health care facilities in the first half of 2021. Bone Therapeutics has instituted corrective measures to mitigate the impact of the pandemic on recruitment for the trial, in collaboration with its clinical research organization. At this point, Bone Therapeutics does not expect the pandemic delay in recruitment rate to have a material effect on the anticipated completion of recruitment in H1 2022. As a result, Bone Therapeutics still currently expects to deliver top line results in H2 2022 as planned. Should the pandemic continue, Bone Therapeutics may have to re-evaluate these timelines and, in that eventuality, will communicate again to the markets.
The 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.
ALLOB is currently being evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures. This study will assess and compare against placebo, in association with standard of care stabilization surgery, the potential for ALLOB to accelerate fracture healing after 3-months follow-up and prevent late-stage complications in these patients, after a follow-up period of 6 months. ALLOB will be applied by a single percutaneous injection 24-96 hours post-definitive reduction surgery in patients with fresh tibial fractures at risk of delayed or non-union. Following the approval in seven European countries, the study is now in the process of enrolling 178 patients in over 40 sites.