Bone Therapeutics Halts Phase III Trial for Futility, Stocks Plunge

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Shares of Bone Therapeutics have plunged more than 26 percent on the Euronext Brussels stock exchange after the Belgium-based company halted a Phase III trial in osteonecrosis of the hip after an interim analysis indicated the study would not meet endpoints.

On Wednesday, Bone said it will halt the PREOB Phase III trial after the Data and Safety Monitoring Board recommended terminating the trial due to the fact it’s unlikely the primary objective will not be achieved at final analysis. The Phase III trial was evaluating 44 patients who have osteonecrosis of the hip. In an interim examination of the trial data, the board said treatment with PREOB, an autologous osteoblastic cell therapy derived from patient bone marrow, was well-tolerated, but not as effective as initially hoped by the company.

As a result of the decision to terminate the Phase III trial, Bone Therapeutics said it will focus its cell therapy development activities and resources on its off-the-shelf, allogeneic platform, ALLOB. Bone noted that allogenic cells are differentiated cells that are derived from ex vivo cultured bone marrow cells of healthy donors. Those cells have demonstrated stronger osteogenic properties than PREOB cells, Bone said. In its announcement, Bone said it is possible to deliver a dose five times greater with allogenic cells than with PREOB. Because of this, Bone said it is more economically viable to pursue ALLOB than PREOB.

By discontinuing the osteonecrosis of the hip study and focusing on ALLOB, Bone said it can pursue additional indications that have different physiopathology, larger patient populations and faster clinical trial recruitment.

Bone Therapeutics Chief Executive Officer Thomas Lienard said the interim results from the Phase III PREOB trial were disappointing. However, he said with the shift of focus to ALLOB, the company believes that will offer a more compelling and commercially-viable solution to address unmet needs in orthopedics and bone disease.

“The discontinuation of the PREOB study will allow us to fully focus on this more promising platform and accelerate its development. Our lead programs in delayed union fractures and spinal fusion have continued to deliver encouraging results. We will also continue to focus resources on JTA-004 in patients with knee osteoarthritis, following the favorable efficacy and safety profile announced last month,” Lienard said in a statement.

With its ALLOB line, Bone Therapeutics is looking to begin a Phase IIb trial in delayed union fractures following positive results from a Phase I/IIa study. Also, Bone Therapeutics said it expects to report top=line results from 32 patients who are part of a Phase IIa spinal fusion study in mid-2019.

In October, Bone Therapeutics announced promising results its first efficacy study of its patented, non-cellular viscosupplement JTA-004 in patients with moderate symptomatic knee osteoarthritis, Bone said the results support future clinical development of the product.

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