Daiichi Sankyo Announces Positive Results with Experimental Oral Factor Xa Inhibitor Study

At the Annual Congress of the European Society of Cardiology, a team led by investigator Dr. Gary Raskob with Daiichi Sankyo - sole developer of the experimental oral Factor Xa inhibitor DU-176b - presented data from a 903 patient phase II study, showing there was a statistically significant dose response in efficacy, and the bleeding rates were low across the four arms.



The study consisted on dividing 903 patients in Europe and the U.S. undergoing total hip replacement surgery, in a randomized, double-blind comparative study examining the safety and efficacy of four doses of DU-176b: 15, 30, 60 and 90 mg once daily versus the low molecular weight heparin, dalteparin.



The results revealed that the incidence of venous thromboembolism were 28.2, 21.2, 15.2 y 10.6 percent in the 15, 30, 60 and 90 mg DU 176b doses, against the 43.8 percent of dalteparin. The bleeding incidence was 0 percent in the dalteparin group versus 1.6, 1.8, 2.2 and 2.3 percent in the DU 176b arms.

The experimental drug is also being studied for treatment of arterial thromboembolism.

With these encouraging results “we expect to commence phase III studies for DU-176b, targeting patients with atrial fibrillation before the end of 2008,” said John Alexander M.D., President of Daiichi Sankyo Pharma Development.