Bone Therapeutics Receives Clearance for Allob Phase I/IIa Trial
Belgian biopharmaceutical firm Bone Therapeutics SA has received clearance from the Competent Authorities in Belgium and the United Kingdom for a Phase I/IIa trial with its allogeneic cell therapy product to treat delayed union fractures - bones that have not healed within the expected normal period of time after the initial injury (i.e., three to four months) and is at risk of non-healing. Roughly 1 million patients are affected by delayed union fractures each year, according to industry estimates. Traditional options for the treatment of impaired fracture healing typically involve highly invasive surgery, which can be painful and require months of rehabilitation with no guarantee of success..
Allob is an allogeneic, osteoblastic (i.e. bone-forming) cell therapy product that has shown safety and efficacy in preclinical studies and potentially could become a first-line treatment for impaired fracture healing due to its minimally invasive percutaneous administration.
This first-in-human, proof-of-concept, 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. Thirty-two patients will be enrolled in 10 centers; each will receive a single percutaneous administration of Allob directly into their fracture site. Allob-treated patients will be assessed in comparison to baseline at two weeks as well as one, three and six months using clinical (e.g., pain, weight-bearing) and radiological evaluation.
Bone Therapeutics already has secured both ‘tissue establishment’ and ‘GMP’ accreditation for in-house manufacturing of Allob.
“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," Bone Therapeutics CEOEnrico Bastianelli said. "The only way to address delayed union fractures currently is invasive surgery which could have severe complications and a long hospital stay. With Allob’s bone regenerative mode of action and minimally invasive administration, Bone Therapeutics’ allogeneic product could become a first-line treatment.”
Allob has been classified as a tissue engineered product under the ATMP regulation 1394/2007 EMA.
Bone Therapeutics is an international biopharmaceutical company focused on innovative cell therapy products for the treatment of bone diseases. The company's lead product, Preob, is an autologous bone cell product currently in Phase III clinical trials for the treatment of osteonecrosis and non-union fractures as well as in a Phase II trial for severe osteoporosis. Founded in 2006, Bone Therapeutics is privately held and headquartered in Gosselies (south of Brussels), Belgium.