Positive Efficacy Data from ALLOB Phase IIA Spinal Fusion Trial
Results from the first half of patients in a Phase IIA spinal fusion trial with Bone Therapeutics' ALLOB® show evidence of successful fusion and clinical improvements in function and pain at 6 months. All patients reached primary and secondary endpoints at 12-month follow-up.
Specifically, fusion was observed in 6 of 8 patients at 6 months and in all patients at 9 and 12 months. Back and leg pain improved by >50% and >80% respectively, from 6 months throughout the follow-up period. Clinical evaluation demonstrated a 33% improvement in functional disability score at 6 months, which increased to 40% at 12 months.
Full data is expected in 2Q17.
The Phase IIA trial in lumbar spinal fusion is designed to evaluate the safety and efficacy of the addition of ALLOB® to the standard of care procedure for degenerative disc disease in which an interbody cage with bioceramic granules is implanted to achieve fusion of the lumbar vertebrae.
Other ALLOB studies underway include treatment of multiple delayed-union fractures, delayed-union fractures and the revision of failed spinal fusion.
Sources: Bone Therapeutics; ORTHOWORLD Inc.