Trigen's TGN 255 shows promise in hemodialysis

German drug developer Trigen says that data from a Phase II trial of TGN 255, a direct thrombin inhitor intended for use in the prevention of clot formation during hemodialysis, show that the drug was effective in a dose-dependant manner. The findings were presented at the European Renal Association and European Dialysis and Transplantation Association congress, held in Glasgow, Scotland.

The study, which enrolled 28 hemodialyisis patients in an open-label, multicenter program, was designed to assess the safety of the compound when administered as a continuous, extracorporeal infusion. Initially, subjects received heparin in order to establish a baseline, before being treated with a range of doses of the product for a maximum of three dialysis sessions.

The results showed that TGN 255 was associated with decreased extracorporeal circuit clotting, and displayed a clear dose-related response in terms of recongized coagulation parameters. The firm also reported that the drug was safe and well tolerated, adding that plans for its continued development were at an advanced stage.