BONE THERAPEUTICS, the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces it has published the results of its Phase I/IIa clinical trial with ALLOB, Bone Therapeutics’ allogeneic bone cell therapy, in patients with delayed union fractures. The results were published in Stem Cell Research & Therapy, the international peer-reviewed journal focusing on translational research in stem cell therapies.
“Approximately 5 to 10% of all long bone fractures do not heal adequately, evolving to delayed union and nonunion fractures. Currently, the only viable treatment options are to undergo painful corrective surgery with significant disease burden and long recovery times. There are estimated over 1.7 million procedures for delayed union and nonunion fractures in the EU5, US and Japan alone (1). These conditions have an enormous physical and socioeconomic impact on patients, their family and the wider society,” said Sven Kili, MD, interim Chief Medical Officer at Bone Therapeutics. “These promising Phase I/IIa ALLOB results are a further demonstration of the potential for allogeneic bone cell therapy as a valuable, cost effective alternative for these patients.”
The Phase I/IIa study was a six-month open-label trial. It evaluated the safety and efficacy of ALLOB in the treatment of delayed-union fractures of long bones. The study evaluated 21 patients. Each patient had a fracture that had failed to consolidate between three and seven months. Each patient received a single percutaneous administration of ALLOB directly into the fracture site and completed a six-month follow-up. Fracture healing of ALLOB-treated patients was assessed using both radiological evaluation (based on CT-scan) and clinical evaluation (including health status and pain).
The results published confirmed that ALLOB was generally well-tolerated and that all patients met the primary endpoint, defined as an increase of at least two points on the radiological Tomographic Union Score (TUS) or an improvement of at least 25% of patients’ health status as measured by the clinical Global Disease Evaluation (GDE) score vs. baseline at six months post administration.
ALLOB is also currently being evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk fractures in the shinbone (tibia). This study will assess and compare against placebo the potential for ALLOB to accelerate fracture healing and prevent late-stage complications in these patients, in association with standard of care stabilization surgery after a follow-up period of 6 months. ALLOB will be applied by a single percutaneous injection 24-96 hours post-definitive reduction surgery in patients with fresh tibial fractures at risk of delayed or non-union. Following the approval in seven European countries, the study is now in the process of enrolling 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 resulting in fewer accidents and reduced availability of health care facilities that may result in negative impact on recruitment rates.