Isotechnika reports positive results from Phase IIb kidney transplant study

This trial was designed to determine the most appropriate dosing strategy for the Phase III program in kidney transplantation. The primary efficacy objective of this trial was to demonstrate non-inferiority in biopsy proven acute rejection (BPAR) in de novo kidney transplant patients receiving voclosporin as compared to tacrolimus at six months. This objective was achieved and non-inferiority was established for each of the three voclosporin treatment groups.

A statistically lower incidence of new onset diabetes mellitus (NODM) at six months post transplantation was observed in the low dose voclosporin group compared to the tacrolimus group (1.6% versus 16.4%, respectively). Although not statistically different, the incidence of NODM was also noted to be lower in the mid-dose voclosporin group compared to the tacrolimus group (5.7% versus 16.4%, respectively).

Robert Foster, Isotechnika’s chairman and CEO, said: “Promise has shown that the efficacy of voclosporin is statistically non-inferior when compared to the market leader, tacrolimus in all three dose groups. While matching tacrolimus in efficacy, key safety advantages such as a lower incidence of NODM and preservation of kidney function were shown.”