Daiichi Sankyo reports on Factor Xa inhibitor

Japanese drugmaker Daiichi Sankyo presented results from a study of investigational oral Factor Xa inhibitor DU-176b in the incidence of venous thromboembolism during elective unilateral hip-replacement surgery at the congress of the European Society of Cardiology in Germany.

The randomized, double-blind, comparative trial examined the safety and efficacy of four doses of DU-176b (15mg, 30mg, 60mg and 90mg once daily) versus the low molecular weight heparin, dalteparin. The study was conducted among 903 patients in Europe and North America undergoing total hip-replacement surgery. There was a statistically-significant dose response in efficacy (p <0.01), and the observed bleeding rates were low across the groups, says the firm.

"As the company that discovered one of the first Factor Xa small molecules (DX-9065a), we are proud to be building on our innovation in cardiovascular disease and tackling the need for better and more effective ways to prevent thrombosis," said John Alexander, president of Daiichi Sankyo Pharma Development. "We expect to commence Phase III studies for DU-176b, targeting patients with atrial fibrillation, before the end of 2008," he added.