Bone Therapeutics Bullish on Primary Trial Results of Cell-Based, Bone-Forming Product

Bone Therapeutics, a Belgium-based bone cell therapy company, has released positive efficacy results for the first cohort of four patients enrolled in the Phase I/IIA delayed-union trial with its allogeneic bone-forming cell product called Allob. Results from the initial four patients showed that all four patients treated with the new product met the primary endpoints of the study and three patients have completely healed.

The trial kicked off in June last year.

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 first cohort of four patients with a fracture that had not consolidated after a minimum of three and a maximum of seven months has been treated.

Each patient received a single percutaneous administration of Allob directly into the fracture site.
Fracture healing of Allob-treated patients is assessed in comparison to baseline at two weeks, one, three and six months using clinical (e.g., pain, weight bearing) and radiological evaluation. Treatment success will have been achieved when the health status of the patient has improved by at least 25 percent and the radiological score, as assessed by computed tomography scan, has increased by at least two points versus baseline, according to the company.

The fact that three out of the four treated delayed-union fractures have fully consolidated in such a short period of time demonstrates the strength of this product, company officials insist. Safety in the study was also recently confirmed by a safety monitoring committee, which unanimously recommended the trial should progress as planned.

“These results, coupled with the recent confirmation of safety in the trial, are very encouraging,” said Enrico Bastianelli, CEO of Bone Therapeutics. The radiological improvement confirms that the treatment is, so far, successful and confirms our belief that Allob will offer significant benefit to patients. We are looking forward to progressing the trial to the next cohort of patients.”

Allob also is part of a proof-of-concept trial for use in spinal fusion.

According to the company, Allob has the potential to become a first-line treatment for impaired fracture healing, thanks to its minimally invasive percutaneous administration. Delayed union fractures, defined by the absence of fracture healing after 3 months, affect around 600,000 to 900,000 new patients a year in Europe and the United States. The current standard of care for delayed union fractures involves highly invasive surgery, which takes up to several hours, followed by a long hospitalization. By contrast, this first administration of Allob required about 20 minutes and took place at the day-clinic. It is injected by the orthopedic surgeon in a single dose percutaneously, directly into the fracture site. No side effects have yet been reported.