SAN DIEGO, Feb. 14 /PRNewswire-FirstCall/ -- Metabasis Therapeutics, Inc. announced today that it has initiated a Phase 1 human clinical trial of MB07803, a potential treatment for patients with type 2 diabetes. MB07803 is the second of a new class of drugs discovered by Metabasis that regulates glucose production in the liver by inhibiting an enzyme known as fructose 1,6 bisphosphatase (FBPase), a key component of the pathway responsible for the production of glucose known as the gluconeogenesis pathway. Metabasis retains all development and marketing rights to MB07803.
The first drug candidate in this class, CS-917, also discovered by Metabasis, is being developed in collaboration with Sankyo Co., Ltd. and has shown promise as a treatment for diabetes in preclinical and early clinical studies. Currently, the safety and efficacy of CS-917 are being studied in a multi-center, double-blind, placebo-controlled Phase 2b clinical trial. Sankyo funds and directs the clinical development of CS-917.
Targeting FBPase represents a new therapeutic approach, discovered by Metabasis, designed to potently and selectively control liver glucose production by specifically inhibiting the gluconeogenesis pathway. An over-active gluconeogenesis pathway is responsible for the abnormal overproduction of glucose in the liver of patients with type 2 diabetes. Thus, by specifically inhibiting gluconeogenesis, liver glucose production should be reduced and blood glucose levels decreased. 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 majority of patients.
While MB07803 is structurally different from the first generation compound and was designed to have certain pharmacological advantages over CS-917, both compounds are designed to inhibit gluconeogenesis by targeting FBPase. 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 glucose levels. Metabasis believes that if the promise of this potential new class of drugs is realized upon further clinical evaluation and both products are ultimately approved for use, both could find wide usage. If successfully developed, these drug candidates are expected to be used alone or in combination with certain other diabetes therapies that target the removal of glucose from the blood.
Dr. Mark Erion, Metabasis' Chief Scientific Officer and Executive Vice President of Research and Development said, "We are very excited about the potential of FBPase inhibition as a new approach for treating type 2 diabetes. Diabetes is a major medical problem throughout the world with devastating and costly consequences. Based on estimates by the World Health Organization and the International Diabetes Federation, type 2 diabetes afflicted 85-95% of the 194 million diabetic patients worldwide in 2003 and will afflict approximately 283 million to 316 million people worldwide by 2025. If approved for use, CS-917 and MB07803 used alone or in combination with other drugs could prove to be important new therapies for combating this widespread disease."
Dr. Paul Laikind, Chairman, President and CEO of Metabasis stated, "The significance to Metabasis of the initiation of clinical development of MB07803 goes beyond being the second of what could prove to be a major new class of drugs for treating diabetes. This milestone is also important to Metabasis for a number of other reasons. First, MB07803 is our fourth internally discovered product candidate to enter clinical development. In addition to MB07803, our clinical stage pipeline includes CS-917, being studied in a Phase 2b trial; pradefovir, a novel product candidate for the treatment of hepatitis B expected to enter Phase 3 trials this year; and MB07133, a novel product candidate for the treatment of primary liver cancer being studied in a Phase 1/2 trial. Second, it is the first of two clinical introductions planned for 2006. The second is a first-in-class clinical candidate, MB07811, which has the potential to be a new treatment for reducing serum cholesterol. If all goes according to plan, we expect that MB07811 will enter the clinic around mid-year. Finally, the fact that we are internally developing MB07803 reflects our strategy to increase participation in the development of our product candidates and retention of commercial rights where appropriate. "
About Metabasis (http://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 MB07803 and CS-917, the efficacy of FBPase inhibition as a therapeutic approach, the market for MB07803 and CS-917 and other potential drugs in their class, and the initiation of clinical trials for, 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 initiation, 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.
