Bone Therapeutics treated the first patient in the ALLOB Phase IIB clinical study treating patients with difficult-to-heal tibial fractures.
The randomized, double-blind, placebo-controlled study is examining the potential of the ALLOB allogeneic cell therapy platform vs. placebo to accelerate fracture healing and prevent late-stage complications in patients with complex fractures in the tibia, on top of standard of care after 6 months follow-up. ALLOB will be applied by a single percutaneous injection 24 to 96 hours post-reduction surgery in patients with fresh tibial fractures who are at risk for delayed or non-union.
The study is expected to enroll 178 patients in over 40 sites throughout Europe. Patient recruitment is slated for completion in 1H22, followed by topline results in 2H22.
“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. “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.”