Bone Therapeutics announced positive 24-month follow-up results for the Phase IIa study with ALLOB allogeneic cell therapy in patients undergoing lumbar spinal fusion.
The data show a successful lumbar vertebrae fusion of 90%, with continued clinical improvements in function and pain, from as early as six months after treatment, up to the 24-month follow-up period.
The multi-center, open-label proof-of-concept Phase IIa study evaluated 30 patients treated with ALLOB; 29 patients attended the 24-month visit.
“This positive data for lumbar spinal fusion complements the strong Phase I/IIa results from ALLOB in patients with delayed union fractures,” said Miguel Forte, M.D., Ph.D., Chief Executive Officer of Bone Therapeutics. “These studies provide promising clinical evidence for the potential of Bone Therapeutics’ unique allogeneic cell therapy platform to address high unmet medical needs in orthopaedics and bone related disorders. We will now hold discussions with global regulators and our partners to explore a variety of options for the next stages of clinical development for ALLOB in different orthopedic indications, while pursuing the phase IIb study of ALLOB in difficult tibial fractures. In addition, the clinical results provide further evidence for the expansion of ALLOB and our platform of differentiated MSCs to other indications.”