Bone Therapeutics may have escaped the graveyard thanks to a buyout by Medsenic last year, but the merged company continues to be haunted by clinical difficulties.
A phase 2b trial of ALLOB, an allogeneic stem cell therapy that was Bone’s lead product, has been suspended by its successor BioSenic after the candidate failed to show it could accelerate the healing of bone fractures. The therapy was given to patients a couple of days after their fracture—as opposed to a previously successful midphase study where it was administered between three and seven months later, BioSenic noted in a June 19 release.
Despite missing the latest trial’s primary endpoint, BioSenic Chief Medical Officer Lieven Huysse, M.D., said the 57-person study “can confirm the excellent safety profile of ALLOB injections, with no reported serious adverse events related to the experimental treatment.”
However, the new data suggest that ALLOB should only continue to be trialed “outside the acute early post-traumatic inflammatory period,” the biotech said in the release.
“In short, ALLOB treatment remains of potential benefit as an add-on to standard of care, at the right time, to improve recovery from extreme bone damage,” the company claimed. “This should be of great help in either after trauma or after bone surgeries.”
It’s not a route that the company is eager to walk itself. Instead, BioSenic will focus its energies on oral arsenic trioxide, which was brought into the company’s portfolio from autoimmune-focused Medsenic. BioSenic is gearing up for a phase 3 trial in chronic graft-versus-host disease, an indication where the therapy has already had midphase success.
“BioSenic has chosen to focus resources on its most promising and advanced asset, the Medsenic OATO autoimmune disease platform,” CEO François Rieger, Ph.D., said in the release. “The decision to halt the clinical development on difficult tibial fractures enables BioSenic to add additional resources for the development of the OATO platform and its current indications.”
The failure of ALLOB could be the final nail in the coffin for Bone Therapeutics’ legacy. The therapy was the last asset in the clinic after it dropped its previous lead candidate JTA-004 in 2021 when the plasma protein solution failed to improve knee pain in a phase 3 trial.
The only hope of keeping the flame alive may be found in a new analysis of the phase 3 data obtained by BioSenic, which the company said last month it would use as the basis to try and seek partners (PDF) to develop JTA-004 further.
The Belgian biotech's stock had dropped 25% on the Brussels stock market to 8 euro cents by midday local time.