Bone Therapeutics, a bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, has completed the recruitment of the first 16 patients in its phase I/IIA delayed-union study of its allogeneic cell therapy product ALLOB.
The ongoing phase I/IIA study is a six-month open-label trial to evaluate the safety and efficacy of ALLOB in the treatment of delayed-union fractures of long bones. The study is targeting the recruitment of 32 patients, but is flexible and could be stopped prematurely after a positive evaluation of the interim data analysis of the first 16 patients. To date, 16 patients with a fracture that has failed to consolidate after a minimum of three and a maximum of seven months, have received a single percutaneous administration of ALLOB directly into the fracture site. Fracture healing of ALLOB-treated patients is assessed using clinical (e.g. pain, weight bearing) and radiological evaluation. Initial results from the first eight patients showed that more than 85% of the patients were responder according to the protocol.
Thomas Lienard, CEO of Bone Therapeutics, commented: “The successful recruitment of 16 patients for the ALLOB phase I/IIa delayed-union study is an important milestone for the company. Positive interim results for this first set of 16 patients could allow us to stop the study early, and would further validate our allogeneic strategy and the potential benefits it can bring to patients. We are encouraged by the previously reported positive preliminary safety and efficacy results of the first eight patients and are looking forward to communicating on the results of the interim data analysis of all 16 patients in the second half of this year, following the completion of the six-month follow-up period.”