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Bone Therapeutics

Pipeline

Bone Therapeutics has developed 2 first-in-class products, PREOB® and ALLOB®, which target 6 indications and offer the potential for additional product extensions.

In addition, Bone Therapeutics is conducting preclinical research on next generation product candidates such as combined cell-matrix products for large bone defects and maxillofacial applications or enhanced viscosupplementation for osteoarthritis.

Phase III clinical trial for PREOB® in osteonecrosis

This pivotal trial will evaluate the safety and efficacy of the minimally invasive administration of PREOB® to patients with early-stage osteonecrosis of the hip. The study will enrol 130 patients of which half will receive a single percutaneous administration of PREOB®, while the other half will receive a placebo via the same procedure.

Preparations are in progress to initiate Bone Therapeutics' first clinical trial in the US for this indication.

Phase IIB/III clinical trial for PREOB® in non-union fractures

This study aims to evaluate the safety and efficacy of PREOB® in the treatment of non-union fractures. In this trial, 176 patients will be randomized to either receive a single percutaneous administration of PREOB® or a bone autograft (the current standard-of-care). The study will evaluate the non-inferiority of the minimally invasive administration of a single PREOB® dose in comparison with the highly invasive standard-of-care, bone autograft.

Phase I/IIA clinical trial for ALLOB® in delayed-union fractures

This first-in-kind study will evaluate the safety and efficacy of Bone Therapeutics' off-the-shelf product, ALLOB®, in delayed-union fractures. The study will enrol patients with a fracture that has not been healed after minimum 3 and maximum 7 months. The study is intended to offer a treatment for patients who currently remain untreated.

Phase IIA clinical trial for ALLOB® in spinal fusion

This proof-of-concept study was designed to evaluate the safety and efficacy of ALLOB® in lumbar spinal fusion. The study will enrol 16 patients with symptomatic degenerative lumbar disc disease that require single level lumbar fusion. An interbody cage will be implanted according to the standard-of-care surgical approach, which will be supplemented with ALLOB® mixed with β-TCP granules (to promote bone formation during the lumbar interbody fusion). The use of a synthetic ceramic scaffold mixed with osteoblastic 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 three-dimensions. This approach is intended to decrease the number of failed fusions and avoid the need of revision surgery.

Phase IIA clinical trial for ALLOB® in the treatment of failed spinal fusions

The study is a pilot, open, proof-of-concept Phase IIA trial to evaluate the safety and the efficacy of ALLOB® implantation in rescue spinal fusion over 12 months. Sixteen patients diagnosed with a failed lumbar spinal fusion at 15 months or more following the initial surgery, and requiring a rescue surgery, will be treated with a single percutaneous implantation of ALLOB® cells into the failed fusion area. The process is monitored by fluoroscopy to visualize and optimize the exact location of administration. The efficacy of the treatment will be evaluated clinically and radiologically by CT-scan.

Phase IIA clinical trial for PREOB® in severe osteoporosis

This study aims to demonstrate the safety and efficacy of PREOB® in the treatment of osteoporotic patients who do not respond to pharmacological treatments. In this trial, 20 patients will be treated with a single intravenous infusion of PREOB®.

Following the safety and efficacy results of the first patient cohort, the Company decided to enhance the value of the osteoporosis program by transitioning to allogeneic development. The initiation of a controlled Phase IIB study with ALLOB® is currently being prepared.