Bone Therapeutics, the regenerative therapy company addressing unmet needs in the field of orthopaedics via a minimally invasive approach, has received clearance from the Competent Authorities in Belgium, France and the Netherlands to initiate a phase IIb/III trial with its autologous cell therapy product, PREOB, for the treatment of non-union fractures. First patients have already been treated in Belgium.
PREOB is a first-in-class autologous osteoblastic/bone forming cell product. It is positioned as a first-line treatment for non-union fractures as it is administered via a minimally invasive approach directly into the fracture site, thereby avoiding the need for open surgery.
The pivotal phase IIb/III, multi-centre, randomised, open-controlled study will determine the efficacy and safety of PREOB in the treatment of hypotrophic non-union fractures of long bones. PREOB will be compared to bone autograft in a non-inferiority design including a 12 month follow-up. 176 patients will be randomised in two groups in a 1:1 ratio (88 patients in the PREOB group vs. 88 patients in the bone autograft group).
Efficacy and safety will be checked at each scheduled visit over the 12 month follow-up period for all patients using clinical (i.e., pain and function) and radiological evaluation. An interim analysis is planned at the midpoint of the study.
Non-union is a serious fracture complication where the normal process of bone healing is interrupted. In general, if a fracture is still evident at six months post injury, it will remain unhealed without specific treatment. Current standard of care involves invasive surgeries with a high risk of complications. Bone Therapeutics’ cell therapy product, PREOB, could help treat 350,000 patients annually in Europe and North America alone. PREOB is also being evaluated in an ongoing phase III trial for the treatment of osteonecrosis.
Enrico Bastianelli, Chief Executive Officer, Bone Therapeutics commented, “We are delighted to have started this pivotal trial of PREOB for the treatment of non-union fractures, an area of significant unmet medical need. For Bone Therapeutics’ to have two pivotal phase IIb/III trials running simultaneously is quite an achievement. Alongside our allogeneic product pipeline, today’s trial start further strengthens our position as a regenerative therapies leader in the field of orthopaedics.”
EP News Bureau – Mumbai
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