Bone Therapeutics is going to discontinue its cell therapy Phase III trial after finding little hope of success for patients with the bone disease osteonecrosis.
If all had gone as planned, the full trial would have monitored 118 patients over 24 months. However, an interim analysis on 44 patients after 12 months found little evidence that the cell therapy would work.
“The interim results for [the treatment] were a disappointment,” stated the CEO of Bone Therapeutics, Thomas Lienard. The company is now taking steps to stop the trial.
The patients enrolled in the trial suffered from osteonecrosis, a bone disease where the blood supply to bone cells gets interrupted by pressure or trauma, and the bone starts to die.
The patients received Bone Therapeutics’ cell therapy PREOB, which uses the patient’s own bone marrow cells to regrow dead bone.
The therapy was combined with core decompression, a treatment where a surgeon drills a hole into the area of dead bone, reducing pressure and allowing more blood flow. The cell therapy was intended to improve the outcome of core decompression, whose effectiveness is still controversial after decades of use.
Bone Therapeutics will now focus its efforts on its other treatments in development, including an off-the-shelf cell therapy called ALLOB that sources bone marrow cells from donors instead of the patient. ALLOB has shown promising results in a Phase I/IIa trial for repairing bone fractures that take longer than normal to heal, and is undergoing a Phase IIa trial to improve the outcomes of spinal fusion surgery.
“The discontinuation of the PREOB study will allow us to fully focus on this more promising platform, [ALLOB], and accelerate its development,” Lienard said in his statement.
Image from Shutterstock