Bone Therapeutics’ phase III osteonecrosis trial with PREOB hits a new milestone

Gosselies, Belgium

Bone Therapeutics, the regenerative therapy company addressing unmet needs in the field of orthopaedics via a minimally invasive approach, announces that its phase III pivotal trial to treat osteonecrosis with its lead bone forming cell product PREOB is actively running in 30 European centres.

Bone Therapeutics obtained clearance from the competent authorities to launch the pivotal phase III trial with PREOB in osteonecrosis in 2012. 30 centres across Belgium, Germany, France and the Netherlands are active and ready to recruit patients to assess the safety and efficacy of PREOB in early stage osteonecrosis of the femoral head. Osteonecrosis is a rare disease affecting ~200,000 new patients each year in Europe and the USA. There is currently no treatment for osteonecrosis available.

PREOB is a first-in-class autologous osteoblastic/bone forming cell product. PREOB is positioned as a first-line treatment as it is administered via a minimally invasive approach directly into the necrotic lesion, thereby avoiding the need for open surgery. PREOB has already acquired orphan drug status for the treatment of osteonecrosis in both Europe and the USA.

The phase III study will enrol 130 adult patients who will be randomised 1:1 and either receive a single administration of PREOB or placebo into the necrotic lesion using a core decompression procedure. Efficacy and safety endpoints will be determined in all patients at each scheduled visit over the 24-month follow-up period using clinical (i.e., pain and function) and radiological evaluation.

Enrico Bastianelli, CEO, Bone Therapeutics commented, “We are very pleased with the progress of this pivotal phase III trial for our most advanced autologous product PREOB. The significant interest we have seen from the centres so far reflects the excitement from the orthopaedic community in this unique approach.”

Bone Therapeutics