SAN DIEGO, Feb. 1 /PRNewswire-FirstCall/ -- Metabasis Therapeutics, Inc. reported today that Sankyo Company, Limited has initiated a multi-center, double-blind, placebo controlled Phase 2b trial designed to evaluate the safety and efficacy of CS-917 for the treatment of patients with type 2 diabetes. Patients in the study will receive CS-917, placebo or an active comparator for a period of three months. CS-917, a first-in-class, orally active, inhibitor of FBPase, an enzyme that regulates production of glucose in the liver, has shown promise as a treatment for diabetes in preclinical and early clinical studies. Sankyo is Metabasis' strategic partner and licensee for CS-917 and funds and directs the clinical development of the drug.
CS-917 represents a new therapeutic approach, discovered by Metabasis, designed to potently and selectively inhibit the gluconeogenesis pathway. This pathway is responsible for the abnormal overproduction of glucose in the liver of patients with type 2 diabetes. Thus, by specifically inhibiting this pathway, liver glucose production should be reduced and blood sugar levels decreased. In two previously completed Phase 2a clinical trials involving a total of 185 patients with type 2 diabetes, treatment with CS-917 resulted in clinically and statistically significant reductions in blood sugar levels. If successfully developed, CS-917 is expected to be used alone or in combination with certain other diabetes therapies that target the removal of glucose from the blood.
Patients with type 2 diabetes have chronically elevated blood sugar levels and consequently often suffer from severe complications, including heart disease, stroke, blindness, peripheral vascular disease, kidney disease and death. Normalizing elevated glucose in diabetic patients remains the goal for diabetes drug therapy since the currently available therapies only achieve modest glucose lowering for the vast majority of patients.
The Center for Disease Control and Prevention (CDC) Division of Diabetes Translation estimates that in 2005, 20.8 million people in the United States suffered from diabetes. Approximately 90% of Americans who are diagnosed with diabetes have type 2 diabetes. The number of new cases of diabetes is rising rapidly. Based on estimates by the World Health Organization and the International Diabetes Federation, type 2 diabetes afflicted 85-95% of the 194 million diabetics worldwide in 2003 and will afflict approximately 283 million to 316 million people worldwide by 2025.
About Metabasis (www.mbasis.com):
Metabasis Therapeutics, Inc. is a biopharmaceutical company uniquely focused on the discovery, development and eventual commercialization of novel drugs to address some of the world's most widespread and costly chronic diseases involving pathways in the liver. The Company has established a pipeline that includes clinical stage and preclinical product candidates targeting large markets with significant unmet medical needs. Targeted diseases include major metabolic diseases such as diabetes, hyperlipidemia and obesity as well as liver diseases such as hepatitis and primary liver cancer. Metabasis has developed several proprietary technologies for use in discovering and optimizing drugs, including the NuMimetic(TM) and HepDirect(TM) technologies. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and expertise.
Forward-Looking Statements:
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the design, efficacy and use of CS-917, and the potential and progress of the Company's other clinical and preclinical compounds. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Metabasis' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress and timing of clinical trials for Metabasis' product candidates; the ability to duplicate results from early stage clinical trials in later stage clinical trials; serious adverse side effects or inadequate efficacy of, or serious adverse events related to, Metabasis' product candidates or proprietary technologies; Metabasis' dependence on its licensees or collaborators for the clinical development and registration of certain of its product candidates, among other things; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing Metabasis' product candidates; the potential and progress of preclinical compounds and programs; Metabasis' ability to retain and motivate key management and scientific personnel; and other factors discussed in the "Risk Factors" section of Metabasis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2005. All forward-looking statements are qualified in their entirety by this cautionary statement. Metabasis is providing this information as of this date of this release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Metabasis Therapeutics, Inc.CONTACT: Paul Laikind, Ph.D., Chairman, CEO & President of MetabasisTherapeutics, Inc., +1-858-622-5550
Web site: http://www.mbasis.com/
