Bone Therapeutics extends ALLOB® phase I/IIa trial to Germany

BONE THERAPEUTICS, the regenerative therapy company addressing unmet medical needs in the fields of bone diseases and orthopaedics, announces today that its phase I/IIa trial with the allogeneic¹ osteoblastic cell therapy product ALLOB^® for the treatment of delayed union fractures has been approved by the Paul-Ehrlich-Institute, the national authority in Germany.  

Four major German centres: Universitätsklinikum Köln, Universität Würzburg Orthopädische Klinik, Universitätsklinikum Schleswig Holstein in Lübeck and Klinikum rechts der Isar in München, are now approved to conduct the proof of concept phase I/IIa trial of ALLOB^®, the first ever clinical trial approved for allogeneic differentiated osteoblastic cell therapy product developed for the treatment of orthopaedic conditions. ALLOB^® has already shown bone-forming properties as well as demonstrated safety and efficacy in preclinical studies. A total of nine centres across Belgium and Germany are now approved.

This will only be the second clinical trial approval of an allogeneic regenerative therapy product authorized in Germany in an orthopaedic condition.  The approval demonstrates the robustness of Bone Therapeutics’ application as Germany’s competent authorities are known to have some of the strictest guidelines for the development of Advanced-Therapy medicinal Products (ATmP) which ALLOB^® is classified as.

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. In total, 32 patients will be enrolled in about 15 centres (a further 16 additional patients may be enrolled upon the results of the interim analysis). They will receive a single percutaneous administration of ALLOB^® directly into the fracture site. ALLOB^®-treated patients will be assessed in comparison to baseline at two weeks, one, three and six months using clinical (e.g., pain, weight-bearing) and radiological evaluation.

Traditional options for the treatment of an impaired fracture (i.e., bone graft) typically involve highly invasive surgery, which can be painful and require months of rehabilitation with the risk of serious complications (such as deep bone infection). Due to the risks of the current treatment, orthopaedic surgeons often take a “watch and wait” approach to the treatment of delayed union fractures, sometimes for several months, which delays the patient’s return to a normal life and leads to a significant financial burden to society. ALLOB^® has the potential to become a first-line and early treatment for delayed union fractures, thanks to its minimally invasive administration which avoids the need for surgery.

Enrico Bastianelli, CEO of Bone Therapeutics commented: “The extension of the phase I/IIb study into Germany demonstrates the strong momentum in the clinical development of ALLOB^®, our unique “off-the-shelf” regenerative therapy product. ALLOB^®’s minimally invasive administration and low side effect profile would not only have a significant impact as a first line treatment of delayed union fractures but could also offer potential to treat multiple orthopaedic indications.”

1. Where cells are derived from a healthy, universal donor, rather than the patient.