Posted on Sep 14, 2018, 8 p.m.
Cell therapy treatment for delayed union fractures has met primary endpoint, and is set to move therapy into phase 2b on the strength of data, but the plan is on hold while adopting an industrialized manufacturing process.
Bone Therapeutics’ therapy is allogeneic osteoblastic cell therapy which is derived from bone marrow cells of healthy adult volunteers. Osteoblasts are cells that form new bone, ALLOB is believed to have the ability to accelerate healing processes in patients whose fractures are taking a long time to heal.
21 patients with fractures that had not yet consolidated 3-7 months after the original trauma were enrolled receiving a single injection of ALLOB into their fracture sites. All of the subjects had improved radiological or clinical score resulting in the trial meeting primary endpoint; ¾ of the subjects experienced 2 point improvements or greater on radiological tomographic union score, with the scores improving by 3.84 points on average; and about ¾ of the subjects experiencing at least 25% improvement on clinical global disease evaluation, with patient clinical scores improving by 48% on average at 6 month follow up.
After hitting a secondary endpoint with a clean safety profile the company believes data is supportive to start a phase 2b, but is holding off on filing to run the larger study until late 2019. Gap between trials relates to optimization of manufacturing processes. During preclinical and early phase testing cell therapies can be made using processes which may be ill suited to commercial scale production demands; methods are fine for producing small quantities of high quality cells but lack consistency required for commercial processes.
The biotech is taking the time to ensure manufacturing processes are ready for large scale use, designing an improved process which should increase yield making it easier to ship cells. Additional nonclinical data is need to be generated on cells made using this process before filing to run the phase 2b.
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