Bone Therapeutics, a biotechnology company specializing in the development of innovative cell therapies addressing unmet medical needs in orthopedics and other serious conditions, announced the treatment of the first patient in the Phase IIb clinical study evaluating ALLOB in the treatment difficult-to-heal tibial fractures.
The Phase IIb study evaluating ALLOB in tibial fractures is a placebo-controlled, randomized, double-blind study that aims to evaluate the potential of ALLOB for accelerated healing and prevention of late complications in patients. patients with tibial bone fractures compared to reference treatment (placebo), after a follow-up period of 6 months. ALLOB will be applied as a single percutaneous injection 24 to 96 hours after reduction surgery has been performed in patients with recent tibial fractures who are at risk of delayed union. The study has been approved in 7 European countries (Germany, Belgium, Spain, France, Hungary, Czech Republic and Poland) and provides for the recruitment of 178 patients across more than forty clinical sites. The finalization of patient recruitment is currently scheduled for the first half of 2022 and the main results of the study are expected in the second half of 2022. These dates may change depending on the evolution of the COVID-19 pandemic and the measures of containments that will result.
“The launch of the clinical study of ALLOB in difficult tibial fractures is a key strategic step in the development of Bone Therapeutics. Difficult fractures are an unpredictable pathological condition for which treatment options are very limited and which can lead to lifelong disability or even amputation. For example, we estimate that more than 1.7 million procedures are performed in Europe, the United States and Japan alone (1). Positive results from this study could potentially lead to the discovery of a unique and effective treatment that meets the expectations of this patient population with high medical need, ”comments Miguel Forte, CEO of Bone Therapeutics. “The treatment of the first patient in this Phase IIb study evaluating ALLOB is taking place as initially planned following the positive results of a 24-month Phase IIa clinical trial that evaluated ALLOB in spinal fusion procedures, but also recruitment and of treating patients in the pivotal Phase III clinical study for the evaluation of our improved viscosupplement, JTA-004, in patients with osteoarthritis of the knee. Positive results from these studies evaluating ALLOB would further demonstrate the extraordinary potential of Mesenchymal Stromal Cell-based therapies for the treatment of other unpredictable or severe conditions. “
(1) Bone Therapeutics estimates
Source : Bone Therapeutics