Bone Therapeutics has reported positive efficacy data for its phase IIA spinal fusion trial with Allob. Results of the first half of patients in the study show evidence of successful fusion and important clinical improvements in function, pain and general health as early as six months after treatment, and all patients reached the primary and secondary endpoints at the end of the 12-month follow-up period.
Dynamic X-rays revealed absence of motion of the vertebral bodies in six out of eight patients at six months and in all patients at nine and 12 months. Fusion was further evidenced by computed
tomography scans that show the presence of bone bridges as from 6 months in 75% of assessable patients. Back and leg pain improved dramatically, by over 50% and over 80% respectively, as from six months throughout the follow-up period. In addition, clinical evaluation demonstrated a 33% improvement in functional disability score (using the Oswestry Disability Index) at six months, which further increased to 40% at 12 months. General health status improved 50% after six months and this level was likewise maintained up to 12 months.
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. Primary endpoints of the study are radiological evaluation of fusion, improvement in pain and functional disability and safety. The company was able to demonstrate in preclinical studies that the combination of bioceramics with Allob cells significantly increased new bone formation and fusion in comparison with bioceramics alone.