Bone Therapeutics received regulatory approvals for Clinical Trial Applications for next studies of both of its lead therapeutic candidates for osteoarthritic (OA) knee pain: the pivotal JTA-004 Phase III clinical study targeting OA knee pain (Denmark) and the Phase IIb study of ALLOB allogeneic cell therapy in patients with difficult tibial fractures (in Belgium).
The company is ready to initiate recruitment in both studies as soon as current COVID-19 restrictions allow.
The JTA-004 phase III study is a controlled, randomized, double-blind evaluation of a single, intra-articular injection of JTA-004 to reduce OA vs. placebo or Hylan G-F 20 (Genzyme Biosurgery). The study expects to enroll 676 patients with mild to moderate symptomatic knee OA in 20 centers throughout Europe and Hong Kong.
The ALLOB Tibial Fracture Phase IIb randomized, double-blind, controlled study is examining the fracture healing potential of single-injection ALLOB in patients with difficult fractures in the tibia vs. standard of care alone after six-month follow-up. The study is expected to enroll 178 patients at 40 sites in up to seven European countries.