Bone Therapeutics (EBR:BOTHE) has posted an interim look at data from a small Phase IIa trial of its allogeneic cell therapy in lumbar spinal fusion. The vertebral bodies fused in all 8 of the subjects to complete one year of follow-up, putting Bone Therapeutics on a path it hopes will lead to a series of positive data readouts in 2017.
Gosselies, Belgium-based Bone Therapeutics is testing its allogeneic cell therapy, Allob, in three Phase I/II and Phase II trials, all of which are closing in on the publication of readouts on their primary endpoints. Bone Therapeutics thinks it can address a range of skeletal conditions including delayed-union fractures and failed lumbar fusions by culturing bone marrow cells taken from adult volunteers.
The data posted this week come from a Phase IIa trial of Allob in patients with degenerative disc disease that hasn’t responded to nonoperative interventions for 6 months or more. In the study, Bone Therapeutics administered a population of what it hopes are bone-forming allogeneic cells to 15 subjects, 8 of whom have completed 12 months of follow-up.
The vertebrae of 6 of the subjects with 12 months of follow-up had fused within 6 months, and all 8 of the cohort had reached this state after 9 months. Bone Therapeutics also posted a glance at data against other co-primary and secondary endpoints, including evidence to suggest Allob is improving back and leg pain and functional disability scores, while encouraging the growth of bone bridges.
Bone Therapeutics expects to have 12-month data from all 15 patients ready for analysis by the second quarter of 2017. That sets the company and Allob up for a busy, critical year. A Phase I/II trial of Allob in delayed union fracture and a Phase II program in patients with failed lumbar fusion have primary completion dates within three months of the study that reported data this week.