Ph IIb trial of Isotechnika's ISA247 opens

Canadian drugmaker Isotechnika has enrolled its first patient in a North American Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247.

The trial will be performed at 34 centers across North America, including 29 in the USAand five in Canada. A total of 332 de novo kidney transplant patients will be recruited and placed into one of four separate treatment groups; three different dose groups of ISA247 (0.4mg/kg, 0.6mg/kg and 0.8mg/kg twice daily) compared with the fourth group, a tacrolimus (0.05mg/kg twice daily) control arm.

The primary endpoint of the trial is defined as non-inferiority in biopsy-proven acute rejection episodes in patients receiving the agent for six months as compared to the tacrolimus control. Additionally, kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial.