Jun 29 2010
Astellas Pharma Inc. (Headquarters: Tokyo, President & CEO: Masafumi Nogimori, "Astellas") announced that the company presented results from a Japanese Phase 2 study conducted with ASP1941, a selective SGLT2 inhibitor, at the 70th Scientific Sessions of the American Diabetes Association (ADA) on June 26, 2010 (EST). ASP1941 is designed to block the re-absorption of glucose in the kidney and excrete glucose in the urine. The oral presentation, along with the four poster presentations, on non-clinical pharmacology, clinical pharmacokinetics/pharmacodynamics and a U.S. Phase 2a study, marks Astellas' first appearance at the ADA meeting and demonstrates the company's commitment to find treatments for diabetes.
During the presentation (75-OR), entitled "ASP1941, a Novel, Selective SGLT2 Inhibitor, Was Effective and Safe in Japanese Healthy Volunteers and Patients with Type 2 Diabetes Mellitus," Dr. Atsunori Kashiwagi from Shiga University of Medical Science presented data from a 12-week dose finding study (12.5, 25, 50, 100 mg and placebo) in 361 Japanese patients with Type 2 diabetes mellitus. This study showed dose related and statistically significant decreases in HbA1c compared to baseline and against placebo of up to 1.3% reaching a maximum at the 50 mg dose. ASP1941 reduced body weight dose-dependently and statistically significant by up to 2 kg in the 100 mg group after 12 weeks. All dosages were well tolerated. Based on the results of this dose-finding study, 50 mg has been selected as the dose for the ongoing Phase 3 program in Japan.
SOURCE Astellas Pharma Inc.
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