Positive efficacy data have been reported from a phase 2a study of Allob (Bone Therapeutics), a first-in-class allogeneic osteoblastic cell-therapy product, for lumbar spinal fusion. All of the patients reached the trial’s primary and secondary endpoints at the end of the 12-month follow-up period. Final study results are expected in the second quarter of 2017.
Allob was developed for the treatment of orthopedic conditions and bone diseases. Allogeneic cell therapy involves the harvesting of cells from a healthy donor, rather than from the treated patient. Allob is being evaluated in three phase 1/2a trials for delayed-union fractures, spinal fusion, and the revision of failed spinal fusions. The product received an orphan drug designation from the FDA for two indications: osteonecrosis and osteogenesis imperfecta. In preclinical studies, the combination of bioceramics with Allob cells significantly increased new bone formation and fusion compared with bioceramics alone.
The new phase 2a trial in lumbar spinal fusion was 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. The study’s coprimary endpoints were radiological evaluation of fusion; improvements in pain and functional disability; and safety.
Dynamic x-rays showed fusion (i.e., the absence of motion) of the vertebral bodies in six of eight patients at six months and in all patients at nine and 12 months. Fusion was further evidenced by computed tomography scans, which showed the presence of bone bridges in 75% of evaluable patients. Back and leg pain improved by more than 50% and more than 80%, respectively, throughout the follow-up period. In addition, clinical evaluation found 33% and 40% improvements in the Oswestry Disability Index at six and 12 months, respectively. The patients’ general health status improved by 50% at six months, and this level was maintained at 12 months.
Spinal fusion is the current standard of care for degenerative disc disease to relieve pain and to improve function. However, progression to fusion with current treatments is slow, usually taking 18 to 24 months. Moreover, surgery may result in a lack of fusion and continuing pain, leaving up to 30% of patients unsatisfied with their procedures.
Source: Bone Therapeutics; October 5, 2016.