Astellas Announces Oral Presentation of SGLT2 Inhibitor Detailing Safety and Efficacy in Patients With Type 2 Diabetes at the American Diabetes Association Meeting
By Astellas Pharma Inc., PRNESunday, June 27, 2010
TOKYO, June 28, 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.
In addition to the oral presentation, the posters that are being
presented are as follows:
Date/Time: June 28, 2010 at 12:00 - 2:00 p.m. EST Location: Orange County Convention Center, Orlando, Florida Titles: -- In Vitro and In Vivo Pharmacological Properties of ASP1941, a Novel, Potent and Selective SGLT2 Inhibitor (Poster # 570-P) -- ASP1941, a Novel, Potent and Selective SGLT2 Inhibitor, Improves Hemoglobin A1c and Symptoms of Diabetes in Animal Models (Poster # 562-P) -- ASP1941, a Novel and Selective SGLT2 Inhibitor, Stimulates Urinary Glucose Excretion in Healthy Subjects (Poster # 565-P) -- ASP1941, a Novel and Selective Inhibitor of Sodium- Glucose Co-Transporter 2 (SGLT2), Reduces Fasting Plasma Glucose in Type 2 Diabetes Mellitus Patients Over 28 Days (Poster # 566-P)
About SGLT2 Inhibitor and ASP1941
SGLT (sodium-glucose co-transporters) are membrane proteins that exist on
the cell surface and transfer glucose into cells. SGLT2 is a subtype of the
sodium-glucose co-transporters and plays a key role in the reuptake of
glucose in the proximal tubule of the kidneys. ASP1941 reduces blood glucose
level by inhibiting the reuptake of glucose. ASP1941 is co-developed with
Kotobuki Pharmaceutical Co., Ltd. and is in clinical development in Japan
(Phase 3), the U.S. (Phase 2) and the EU (Phase 2).
About Type 2 Diabetes
Diabetes (medically known as diabetes mellitus) is a disorder in which
the body has difficulty regulating its blood glucose (sugar) level. There are
two major types of diabetes: type 1 and type 2. Type 2 diabetes (formerly
called non-insulin-dependent diabetes mellitus or adult-onset diabetes) is a
disorder that is characterized by high blood glucose in the context of
insulin resistance and relative insulin deficiency. Patients are instructed
to increase exercise and diet restrictions, but most require treatment with
an anti-diabetic agent to control blood glucose.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical
company dedicated to improving the health of people around the world through
the provision of innovative and reliable pharmaceuticals. Astellas has
approximately 15,000 employees worldwide. The organization is committed to
becoming a global category leader in urology, immunology & infectious
diseases, neuroscience, DM complications & metabolic diseases and oncology.
For more information on Astellas Pharma Inc., please visit our website at
www.astellas.com/en.
Astellas Pharma Inc. (Japan), Corporate Communications, +81-3-3244-3201, Fax: +81-3-5201-7473, or Jenny Keeney of Astellas Pharma US, Inc. (US), +1-847-317-5405, Mindy Dooa of Astellas Pharma Europe Limited (EU), +44-(0)-1784-419-408
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