BioSenic announced the decision to suspend its interventional trial on fracture healing, using the ex-Bone-Therapeutics lead product, ALLOB. This decision follows negative results obtained for the primary endpoint in the exploratory Phase IIb trial (ALLOB IIb), which focused on safety and treatment timing efficacy. The aim of this Phase IIb study was to evaluate the efficacy of administering ALLOB (derived from mesenchymal stem cells) a couple of days after a bone fracture to accelerate fracture healing.

In contrast to the previous successful Phase IIa, where ALLOB was administered after 3.5 to 7 months, in 21 long bone fractures with documented delayed- or non-union, early application of ALLOB did not accelerate the fracture healing process. BioSenic, through the Medsenic company autoimmune disease platform had completed a successful phase II trial targeting cGVHD (chronic Graft vs Host Disease), with a demonstrated efficacy of more than 75% on the Full Study Population and 84% on the Per Protocol Population. A phase III study is now in the starting blocks to reach the market as quickly as possible, through the framework of an expedite 505(b)(2) FDA regulatory pathway.