The Data and Safety Monitoring Board recommended discontinuation of a Phase III hip osteonecrosis study of Bone Therapeutics' PREOB viscosupplement, following interim analysis of results which suggest that the primary objective would likely not be achieved at final analysis.
The study was a randomized, double-blind, placebo-controlled pivotal trial that was slated to enroll 118 patients to evaluate use of 20 million PREOB cells in treatment of early-stage osteonecrosis of the femoral head over two years. Interim analysis at 12 months evaluated 44 patients treated with PREOB plus core decompression or placebo plus core depression. The primary endpoint was the percent of responders showing clinically relevant pain relief and no progression to fracture.
Bone Therapeutics will now more fully focus on its ALLOB off the shelf allogeneic cell platform in the treatment of delayed union fractures and spinal fusion, as well as the JTA-004 viscosupplement to treat knee osteoarthritis.
Sources: Bone Therapeutics; ORTHOWORLD Inc.