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Daiichi Sankyo Reports Phase-2 Data for DU-176b

[This oral FXa inhibitor has had a very much lower profile than Xarelto and Apixaban, which may be attributable to the fact that investors pay more attention to US-based Big Pharma than to Japanese companies. The phase-2 trial in hip surgery was a success, and a phase-3 trial in AF is expected to begin before year-end. One oddity of the phase-2 trial is that Fragmin (dalteparin) rather than Lovenox was used as the comparator drug.]

http://biz.yahoo.com/prnews/080902/nytu045.html

›Tuesday September 2, 2:31 am ET

MUNICH, Germany, Sept. 2 /PRNewswire-FirstCall/ -- Data presented today at the Annual Congress of the European Society of Cardiology showed that the investigational oral Factor Xa inhibitor DU-176b reduced the incidence of venous thromboembolism (VTE) compared with dalteparin among patients undergoing elective unilateral 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. DU-176b is being developed solely by Daiichi Sankyo Company, Limited and the data were presented by lead investigator Dr. Gary Raskob.

This randomized, double-blind comparative study examined 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 study was conducted among 903 patients in Europe and North America undergoing total hip replacement surgery.

"These findings are encouraging and we look forward to further study on this Factor Xa inhibitor," said Gary Raskob, Ph.D., Dean, College of Public Health at the University of Oklahoma Health Sciences Center. "These findings indicate DU-176b may provide a high degree of efficacy, but further study is needed."

"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 M.D., president, Daiichi Sankyo Pharma Development. "We expect to commence phase III studies for DU-176b, targeting patients with atrial fibrillation, before the end of 2008.”

Study Result Details

VTE incidence (%) Bleeding occurrence*** (%)

Dalteparin 43.8 [35.5-52.3]# 0 [0-2.1]
DU-176b 15mg 28.2 [21.6-35.6]* 1.6 [0.3-4.5]
30mg 21.2 [15.0-28.6]** 1.8 [0.4-5.1]
60mg 15.2 [10.0-21.8]** 2.2 [0.6-5.4]
90mg 10.6 [6.2-16.6]** 2.3 [0.6-5.7]

#95% confidence interval, * p=0.005, **p<0.001, ***Major+Clinically
Relevant


About DU-176b

DU-176b is an oral anticoagulant that directly inhibits Factor Xa, a clotting factor in the blood. Daiichi Sankyo is developing DU-176b as a potential new treatment for the prevention of both arterial and venous thromboembolism.

About Daiichi Sankyo

A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., headed by President Takashi Shoda was established in 2005 through the merger of two leading Japanese pharmaceutical companies, Daiichi Pharmaceutical Co., Ltd. and Sankyo Co., Ltd. This integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. A central focus of Daiichi Sankyo's research and development is cardiometabolic diseases, including therapies for thrombosis, dyslipidemia, hypertension, diabetes, and acute coronary syndromes. Equally important to the company is the discovery of new medicines in the areas of infectious diseases, cancer, bone and joint diseases, and immune disorders. For more information, visit www.daiichisankyo.com.‹