BONE THERAPEUTICS, the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces it has treated the first patient for the ALLOB Phase IIb clinical study in patients with difficult-to-heal tibial fractures.
The ALLOB Tibial Fracture Phase IIb study is a randomized, double-blind, placebo-controlled study. In this study, the potential of ALLOB to accelerate fracture healing and prevent late-stage complications in patients with difficult fractures in the shinbone (tibia), will be evaluated and compared to placebo, on top of standard of care after a follow-up period of 6 months. ALLOB will be applied by a single percutaneous injection 24-96 hours post reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union. The study has been approved in 7 European countries (Belgium, Czech Republic, France, Germany, Hungary, Poland and Spain). The study is expected to enroll 178 patients in over 40 sites. Bone Therapeutics anticipates finalizing patient recruitment in H1 2022. Topline results are expected in second half of 2022. Both events are subject to evolution of the COVID-19 pandemic and the associated containment measures.
"The start of the ALLOB clinical study in difficult tibial fractures is a critical step for Bone Therapeutics. Difficult fractures remain an underserved condition with limited therapeutic options, which can result in lifelong disability and amputations. There are estimated more than 1.7 million procedures in the EU5, US and Japan alone (1). A positive outcome of this study could lead to a valuable treatment for these patients at risk of delayed or non-union fractures.” said Miguel Forte, CEO, Bone Therapeutics. “This Phase IIb first patient treatment for ALLOB follows positive 24-month results for the Phase IIa ALLOB clinical trial in lumbar spinal fusion procedures, as well as our completion of the recruitment and patient treatment of the pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis. The successful completion of Bone Therapeutics’ ALLOB trials would further demonstrate the promise of mesenchymal stromal derived cell therapies for the treatment of other underserved conditions.”
About ALLOB and Bone Therapeutics’ proprietary, scalable cell therapy manufacturing process
ALLOB is Bone Therapeutics’ off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from cultured bone marrow mesenchymal stromal cells (MSC) from healthy adult donors. To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves consistency, scalability, cost effectiveness and ease of use of ALLOB. This optimized production process significantly increases the production yield, generating thousands of doses per bone marrow donation. Additionally, the final ALLOB product is cryopreserved, enabling easy shipment and the capability to be stored at the point of care for easy clinical use. The process will therefore substantially improve product quality, reduce overall production costs, simplify supply chain logistics, increase patient accessibility and facilitate global commercialization. The Company has implemented the optimized production process to produce clinical batches for the ongoing Phase IIb clinical trial in patients with difficult-to-heal tibial fractures.
(1) Bone Therapeutics’ estimates.