Bone Therapeutics receives clearance for ALLOB® phase II trial in spinal fusion

BONE THERAPEUTICS, the regenerative therapy company addressing unmet medical needs in the fields of bone diseases and orthopaedics, announces today that it has received clearance from the Competent Authorities and Central Ethics Committee in Belgium for a phase II proof-of-concept study to assess safety and efficacy of its allogeneic¹ osteoblastic cell therapy product ALLOB^® in spinal fusion procedures for degenerative lumbar disc disease.

Bone Therapeutics aims to investigate ALLOB^®’s potential to fulfil this unmet medical need and improve spinal fusion surgery outcomes. ALLOB^® has already shown the required osteoinductive, osteogenic and osteoconductive features² for bone formation enhancement as well as excellent safety and efficacy in preclinical studies and is currently being evaluated in a phase I/IIa trial for delayed-union fractures. 

In this pilot proof-of-concept study, 16 patients with symptomatic degenerative lumbar disc disease that require interbody fusion will be treated with a single dose of ALLOB^® mixed with bioceramic granules to promote bone formation and fusion at the degenerative disc level.

The use of a bioceramic scaffold mixed with ALLOB^® cells is intended to promote bone formation by (i) providing biologically active osteoblastic cells, (ii) restoring a healthy bone environment, and (iii) guiding growth in 3-dimensions. Patients will be enrolled in 4 centres and safety and efficacy of the treatment will be monitored over 12 months by clinical (Oswestry Disability Index) and radiological (fusion progression) evaluation, with an additional 24-month post-study follow-up.

Back pain is a widespread medical disorder in industrialized societies and several pathologies require spinal surgery. Around 1.3 million spinal fusions are performed each year in Europe and the USA, the majority of which are to address degenerative lumbar disc disease. Despite the frequency of this surgery, non-union of bone and persistent pain following the intervention is still extremely common. Further improvements would thus be extremely beneficial to improve safety and efficacy.

Enrico Bastianelli, CEO of Bone Therapeutics commented, “This new clinical trial clearance from the Competent Authorities in Belgium is an important milestone in the development of ALLOB^® and further validates Bone Therapeutics’ clinical, regulatory and manufacturing capabilities.

1. Where cells are derived from a healthy, universal donor, rather than the patient.
2. Induction of bone formation (osteoinduction), new bone support (osteoconduction) and production of mature bone (osteogenic) are the 3 essential features to healthy bone formation