Bone Therapeutics has announced positive 24-month follow-up results from its phase IIa study of Allob, its allogeneic cell therapy, in patients undergoing lumbar spinal fusion procedures.
The data demonstrated a 90% successful lumbar vertebrae fusion rate at 24 months, with patients also continuing to experience clinical improvements in function and pain.
The results comes from a multi-centre, open-label phase IIa study designed to evaluate the safety and efficacy of Allob.
The main endpoints of the 24-month follow-up included safety and radiological assessments to evaluate vertebrae fusions and clinical assessments to evaluate improvement in patients’ functional disability, as well as reduction in back and leg pain.
Spinal fusion procedures are performed to relieve pain and improve patient’s daily function for a broad spectrum of degenerative spine disorders.
This consists of bridging two or more vertebrae with the use of a cage and graft material for fusing an unstable portion of the spine and immobilising a painful intervertebral motion segment.
“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,” said Miguel Forte, chief executive officer of Bone Therapeutics.
“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 orthopaedic 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,” he added.
By Lucy Parsons
Source: pharmatimes.com
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