Bone Therapeutics cans plan to trial cell therapy in U.S.

("New York. East River. USA Flag" (CC BY-SA 2.0) by Tomás Fano)

Bone Therapeutics (EBR:BOTHE) has scrapped plans to trial its autologous cell therapy Preob in the U.S. The bone fracture specialist had planned to run a Phase IIb/III trial in the U.S. to complement its activities in Europe, but has pulled back from the proposal to focus on its other pipeline prospect.

Gosselies, Belgium-based Bone Therapeutics unveiled the shift in strategy alongside news of the appointment of Thomas Lienard as CEO. Lienard, a sales and marketing executive who joined Bone Therapeutics last year after a career at Lundbeck (CPH:LUN) and Eli Lilly ($LLY), presented the change in focus as ensuring resources are focused on programs with the most potential from a commercial and partnering perspective.

Preob is the main victim of the reprioritization. Bone Therapeutics is continuing a Phase IIb/III trial of the cell therapy in the bone tissue blood supply disease osteonecrosis in Europe. With that trial due to wrap up late in 2018, Bone Therapeutics sees the use of Preob in osteonecrosis as a spearhead for its commercial ambitions. But in the longer term, it is tying its fate to Allob. That means there is no room for a U.S. late-phase trial of Preob.

Bone Therapeutics framed the prioritization of Allob as a reflection of its commercial and industrial strength as compared to Preob. Notably, while Preob uses bone marrow cells taken from patients, Allob relies on materials from donors. The allogeneic approach potentially eliminates some of the logistic and commercial difficulties associated with taking cells from a patient, processing them and administering them back into the individual, as happens in autologous approaches.

The move from autologous to allogeneic approaches started under Lienard ‘s predecessor Enrico Bastianelli, who stepped down as CEO last month after a decade in the role. On Bastianelli’s watch, Bone Therapeutics transitioned its osteoporosis program from Preob to its allogeneic platform. The succession of decisions means Bone Therapeutics expects its cash reserves to last until the second quarter of 2018.

By then, Bone Therapeutics will have a better idea of whether its bet on Allob will pay off. An interim analysis of a delayed-union fracture trial is scheduled for the middle of next year. If positive, Bone Therapeutics will halt the trial and advance into the next stage of development. Efficacy data from a Phase IIa spinal fusion study are due around the same time.