Bone Delayed Union Product Enters Trials

Bone Therapeutics SA has received clearance from the Competent Authorities in Belgium and the United Kingdom for a Phase I/IIa trial of its allogeneic cell therapy product ALLOB for the treatment of delayed union fractures.

A delayed union fracture is defined as a bone that has not healed within the expected normal period of time, three to four months, after the initial injury and is at risk of non-healing. Around one million patients are affected by delayed union each year. Traditional options for the treatment of impaired fracture healing typically involve highly invasive surgery, which can require months of rehabilitation with no guarantee of success.

According to a report by Bone Therapeutics ALLOB is an allogeneic (where cells are derived from a healthy, universal donor, rather than the patient) and osteoblastic (bone-forming) cell therapy product. ALLOB has shown safety and efficacy in preclinical studies and company officials believe that it has the potential to become a first-line treatment for impaired fracture healing, thanks to its minimally invasive percutaneous administration, avoiding the need for surgery.

The 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. Thirty-two patients will be enrolled in 10 centers. 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 and at one, three and six month intervals using clinical and radiological evaluation.

Enrico Bastianelli, CEO of Bone Therapeutics said, “This new clinical trial clearance from the Competent Authorities in Belgium and the UK is an important milestone in the development of ALLOB and further validates Bone Therapeutics’ clinical, regulatory and manufacturing capabilities. The only way to address delayed union fractures currently is invasive surgery. With ALLOB’s bone regenerative mode of action and minimally invasive administration, Bone Therapeutics’ allogeneic product could become a first-line treatment.”

Company officials note that ALLOB also has the potential for systemic applications as in osteogenesis imperfecta, a rare genetic bone disease characterized by bone fragility and fractures. ALLOB has been classified as a tissue engineered product.