Bone Therapeutics Authorized to Enroll Patients in U.K. Clinical Trial

Bone Therapeutics has received regulatory approval to enroll patients in the United Kingdom into a Phase III trial that will measure the safety and efficacy of its regenerative therapy product PREOB in the treatment of osteonecrosis (also known as avascular necrosis, AVN).

Five U.K. sites, including Cambridge University Hospitals, King’s College Hospital London, Newcastle University/Newcastle upon Tyne Hospitals, University Hospital Southampton and The Royal Orthopaedic Hospital Birmingham are approved to participate in the trial. A total of 37 centers across the United Kingdom, Belgium, Germany, France and The Netherlands have received authorization to conduct the Phase III trial of PREOB, which has orphan drug status in Europe and the United States.

“We are delighted to have extended this pivotal study to the U.K. and to be working with such prestigious UK institutions. It is an important step in the acceleration of this study which could see PREOB as a first line treatment in this painful and debilitating disorder,” Bone Therapeutics CEO
Enrico Bastianelli said.

Osteonecrosis is a bone disease characterised by the death of bone tissue, eventually causing the bone to collapse. Osteonecrosis is most common in the hip where the disease causes femoral head collapse and joint destruction, leading to the requirement of a hip prosthesis. About 150,000 patients require total hip replacement due to osteonecrosis each year in Europe and the United States, according to industry statistics.

The Phase III study is a randomized, double-blind, placebo-controlled pivotal trial that aims to confirm the safety and efficacy of Bone Therapeutics’ autologous osteoblastic or bone-forming cell product, PREOB, in early-stage osteonecrosis of the femoral head over a 24-month period in 130 patients. PREOB is designed 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.

“Osteonecrosis is a severely debilitating disease and due to the young age of many patients, sufferers often have to face years of pain until they are deemed old enough for total hip replacement,” saidEdith Brown, co-trustee of the AVN Charity U.K. “A regenerative treatment that could avoid the need for surgery and give long lasting effects from diagnosis would change the lives of so many sufferers and we look forward to the results of this pivotal study.”

Bone Therapeutics’ PREOB is a first-in-class autologous osteoblastic cell product administered percutaneously via a minimally invasive approach, avoiding the need for open surgery. Based on the results of the proof-of-concept Phase II studies, which have shown statistically significant and clinically relevant benefits, PREOB currently is in two pivotal trials in Europe: a Phase III trial in the treatment of hip osteonecrosis and a Phase IIb/III trial in the treatment of long bone non-union fractures. PREOB also entered a Phase I/IIa clinical trial for the treatment of severe osteoporosis.

Bone Therapeutics develops regenerative therapies for the repair and prevention of fractures.It also runs preclinical research programs and develops product candidates.Founded in 2006, the company is headquartered in Gosselies, Belgium (south of Brussels).