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SAN DIEGO, CA - September 26, 2003 -- Metabasis Therapeutics, Inc. announced the completion of a Phase 2A trial on its first-in-class oral gluconeogenesis inhibitor in patients with type 2 diabetes mellitus (diabetes). The results of the trial provide the first evidence that this new class of drugs is capable of significantly reducing blood glucose levels in patients with diabetes. Metabasis' partner on the project since 1997, Sankyo Co., Ltd., is funding and directing the clinical development of the drug. In preclinical studies, CS-917 reduced the overproduction of the sugar called glucose by the liver and thereby lowered blood glucose levels. Patients with type 2 diabetes have chronically elevated blood glucose levels and consequently often suffer from severe complications, including heart disease, stroke, blindness, peripheral vascular disease, kidney disease and nerve damage. The recently completed Phase 2A study was designed to provide evidence that the drug lowered glucose levels in humans. In a randomized, placebo controlled, double blind trial, patients with type 2 diabetes received the drug orally one time daily for a period of fourteen days. Results from this initial study appear promising in that CS-917-treated patients exhibited lower blood glucose levels for the first six hours after dosing on day 14 compared to glucose levels on the day before the first dose was administered. Moreover, glucose lowering was greater in CS-917-treated patients relative to placebo-treated patients. Additional studies are planned for later this year and next year to confirm these results and determine a safe and effective dosing regimen. Dr. Mark Erion, Executive Vice President, Research and Development at Metabasis stated, "We are pleased with what we have learned from this small, early study. The results provide us with the first evidence that CS-917 is able to reduce blood glucose levels in patients with diabetes. Of course, larger studies involving longer treatment periods are required before we can demonstrate that the drug will safely and effectively treat patients. The first of these studies is planned for later this year. Diabetes is a major medical problem throughout the world with devastating and costly consequences. New approaches such as ours are needed to treat this disease." According to the American Diabetes Association, as of 2002 approximately 17 million people in the United States had diabetes. Approximately 90-95% of Americans who are diagnosed with diabetes have type 2 diabetes. The number of new cases of diabetes is rising rapidly. Approximately 900,000 people aged 20 years and older will be diagnosed with type 2 diabetes this year. Diabetes is the fifth-leading cause of death by disease in the United States. Metabasis Therapeutics, Inc. (www.mbasis.com) is a privately held, biopharmaceutical company that develops proprietary products principally for the treatment of liver and liver-related metabolic diseases. Metabasis has expertise in the fields of nucleoside/nucleotide chemistry and metabolism, liver biology and liver-specific drug delivery. Metabasis has discovered and developed a new class of drug candidates for treating diabetes that act to lower liver glucose production in diabetic patients. The first drug candidate from this program, CS-917, is being developed in collaboration with Sankyo Co., Ltd. and is currently undergoing clinical testing. Metabasis has also developed its HepDirect technology that allows liver-specific delivery of new and existing drugs. Two novel drug candidates derived from the HepDirect technology are in clinical testing: a drug for hepatitis B called Hepavir B, developed in collaboration with Ribapharm, Inc., and a drug for primary liver cancer called MB7133, to which Metabasis retains exclusive rights.
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