Metabasis Completes Enrollment Of Its Proof-of-Concept Clinical Trial For MB07803, Its Product Candidate For The Treatment Of Type 2 Diabetes

Main Category: Diabetes
Article Date: 03 Mar 2008 - 4:00 PDT

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Metabasis Therapeutics, Inc. (Nasdaq:MBRX) announced the completion of patient enrollment in its Phase 2a clinical trial for MB07803, a product candidate being studied as a treatment for patients with type 2 diabetes. With this trial fully enrolled and the final patients undergoing dosing, the Company expects to be able to announce top line results in the second quarter of 2008, as planned. MB07803 is a member of a new class of drugs discovered by Metabasis that is designed to regulate glucose production in the liver by inhibiting an enzyme known as fructose-1,6-bisphosphatase (FBPase), a key enzyme in the gluconeogenesis pathway which is responsible for the excessive production of glucose in patients with type 2 diabetes.

The 28-day Phase 2a proof-of-concept study is a randomized, double-blind, placebo-controlled trial involving over 100 patients with type 2 diabetes. Patients received either placebo or MB07803 at an oral dose of 10, 50, 100 or 200 mg once daily. The clinical trial is evaluating the change from baseline on day 28 in fasting plasma glucose (FPG).

MB07803 is a second generation FBPase inhibitor that Metabasis discovered. The Company has completed five Phase 1 clinical trials for MB07803. The results of these studies showed that MB07803 is safe and well-tolerated. The first product candidate in this class, CS-917, also discovered by Metabasis, failed to achieve its primary endpoint in a Phase 2b clinical trial in 2007. Subsequent analysis of the data from the Phase 2b clinical trial for CS-917, completed last year, did show that CS-917 significantly lowered both hemoglobin A1c and FPG in certain patient sub-populations over the three-month dosing period evaluated, and was safe and well-tolerated. Development of this first generation candidate has been discontinued in favor of MB07803, a structurally different compound considered to have several important advantages over CS-917, based on results from pre-clinical and early clinical studies.

"Our second generation FBPase inhibitor, MB07803, was selected for clinical development based on several pre-clinical studies demonstrating that MB07803 had a more favorable pharmacokinetic profile than CS-917 and was more potent," commented Dr. Mark Erion, executive vice president of research and development and chief scientific officer. "Results from our Phase 1 clinical trials were consistent with these findings and supported once-a-day dosing. Moreover, the results suggest that MB07803 may exhibit increased oral bioavailability, reduced metabolism and reduced drug variability relative to CS-917. We believe the improvements in MB07803 make it a better compound that may enable us to unmask the full efficacy potential of FBPase inhibition. The results from the soon to be completed Phase 2a clinical trial will provide important safety and glucose-lowering data in patients with type 2 diabetes and could provide further support for the importance of this new approach for the treatment of patients with type 2 diabetes."

About Type 2 Diabetes

Diabetes is the fastest growing disease in the U.S., afflicting approximately 20 million Americans, or 7% of the population. Diabetes costs in the U.S. were $174 billion in 2007. Worldwide, the disease affects more than 200 million people and accounts for $232 billion for treatment and prevention. Approximately 90% of patients with diabetes throughout the world have type 2 diabetesi,ii. An aging population, poor diets and increased incidence of obesity U.S. and worldwide are contributing to the rapid increase of diabetes prevalencei.

About Metabasis

Metabasis is a biopharmaceutical company using its proprietary technologies, scientific expertise and unique capabilities for targeting the liver and liver pathways. The Company has established a broad pipeline of product candidates and advanced research programs targeting large markets with significant unmet needs. Metabasis' core area of focus is on the discovery and development of drug candidates to treat metabolic diseases such as hyperlipidemia, diabetes and obesity, among others. Although not a core focus of the Company, Metabasis has also discovered and developed drug candidates indicated for the treatment of liver diseases such as hepatitis and primary liver cancer, which it now intends to license or partner. All of our product candidates were developed internally using proprietary technologies.

http://www.mbasis.com

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, the progress, completion and results of clinical trials for MB07803; the potential efficacy and benefits of, and the potential market for MB07803; and Metabasis' strategic goals and corporate objectives. 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 fact that positive results from preclinical studies and early clinical trials does not necessarily mean later clinical trials will succeed; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing Metabasis' product candidates; serious adverse side effects or inadequate efficacy of, or serious adverse events related to, Metabasis' product candidates or proprietary technologies; the risk that Metabasis will not be able to build more value or retain rights for direct commercialization of its product candidates; Metabasis' dependence on its licensees and collaborators for the clinical development and registration of, as well as information relating to, certain of its product candidates; potential conflicts with collaborators that could delay or prevent the development or commercialization of Metabasis' product candidates; the scope and validity of intellectual property protection for Metabasis' product candidates, proprietary technologies and their uses; competition from other pharmaceutical or biotechnology companies; Metabasis' ability to obtain additional financing to support its operations; and other factors discussed in the "Risk Factors" section of Metabasis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and in Metabasis' other filings with the Securities and Exchange Commission. 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.

i The International Diabetes Federation Diabetes Prevalence. Available here. Accessed February 27, 2008.

ii "Economic Costs of Diabetes in the U.S. in 2007." American Diabetes Association. Available here. Accessed February 27, 2008.

Metabasis