Bone Therapeutics Gains Approval to Trial OA Knee Pain Therapies

Bone Therapeutics, the bone cell therapy company addressing high unmet medical needs in orthopedics and bone diseases, has received regulatory approvals for its Clinical Trial Applications for the next studies of both of its lead candidates. These two studies are the pivotal JTA-004 Phase III clinical study targeting osteoarthritic knee pain and the Phase IIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. The JTA-004 trial has been approved by regulatory authorities in Denmark, and the ALLOB by Belgian regulatory authorities.
 
Bone Therapeutics now has completed preparations for these trials. It is ready to initiate recruitment in both of these studies as soon as the current situation regarding COVID-19 allows, in those two countries. Bone Therapeutics has taken this decision to support healthcare systems in the respective trial countries, enabling them to concentrate on treating COVID-19 patients whilst necessary.
 
“Bone Therapeutics is now ready to commence clinical trials on both its lead products. Receiving regulatory approvals for both Clinical Trial Applications completes the preparative activity for both studies,” said Miguel Forte, CEO, Bone Therapeutics. “This means that as soon as the current situation allows, we will be able to start recruiting patients for both clinical studies and continue to develop options for patients suffering knee osteoarthritic pain and difficult tibial fractures, both of which are conditions with a high unmet medical need.”
 
The JTA-004 phase III study is a controlled, randomized, double-blind study. 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 osteoarthritis treatment on the market. The study expects to enrol 676 patients with mild to moderate symptomatic knee osteoarthritis in approximately 20 centers in 7 European countries and Hong Kong SAR.
 
The ALLOB Tibial Fracture Phase IIb study is a randomized, double-blind, controlled study in which the fracture healing potential of ALLOB in patients with difficult fractures in the shinbone (tibia) will be evaluated and compared to standard of care alone after a follow-up period of 6 months. ALLOB will be applied by single percutaneous injection 24-72 hours post reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union. The study is expected to enroll approximately 178 patients in approximately 40 sites in up to 7 European countries.