Bone Cell Therapy Could Treat Resistant Osteoporosis

A novel bone cell-therapy product could help in the treatment of severe osteoporosis patients who do not respond to pharmacological treatment.

Developed by researchers at Bone Therapeutics (Gosselies, Belgium), PREOB is a first-in-class autologous cell therapy product composed of a large population of well-differentiated osteoblastic cells. The cells, which present a large expansion capacity and demonstrated osteogenic potential, display a fast proliferation rate and high mineralization capabilities both in vitro and in vivo. The use of specific culture conditions and a minimally invasive implantation technique that requires no open surgery minimizes patient risk.

PREOB is currently in two pivotal Phase III trials for the treatment of osteonecrosis and nonunion fractures, and it has also initiated a Phase IIa trial with the rheumatology department of Erasme University Hospital (Brussels, Belgium). The Phase IIa study is a six-month open-label trial enrolling 20 patients with severe osteoporosis who do not respond to antiosteoporotic treatment. PREOB will be administered via a single intravenous infusion, and the primary endpoints of the trial will be cell body distribution and bone markers.

“We are very excited to be investigating the potential of PREOB in treatment-resistant osteoporosis, where PREOB’s unique mechanism of action could have a real impact on patients,” said Valérie Gangji, Head of Rheumatology at Erasme University Hospital, part of the Free University of Brussels (Belgium). “A new treatment such as PREOB that could reduce the risk of fracture and form new bone could significantly improve the quality of life of these osteoporotic patients.”

“We are delighted to be expanding the potential of our lead product PREOB to osteoporosis, a large disease area with significant unmet need, under the existing agreement that we have with the Free University of Brussels,” said Enrico Bastianelli, CEO of Bone Therapeutics.

Due to its unique mechanism of action, PREOB could have a significant role to play in the treatment of severe osteoporosis, where over 40% of patients under treatment still lose bone mass and suffer fractures, and the majority of current treatments do not offer anabolic activity as their mechanism of action.

Related Links:
Bone Therapeutics
Erasme University Hospital