Metabasis Therapeutics Presents Preclinical Results for MB07811, Its Novel Product Candidate for the Treatment of Hyperlipidemia at the American Thyroid Association's National Meeting
The first presentation provided data demonstrating that in the animal models studied, MB07811 led to similar reductions in cholesterol and triglyceride levels, but with an improved therapeutic index as compared to the natural ligand, T3, or a prototype non-liver-targeted TR beta-selective agonist (KB-141). Oral administration of MB07811 caused liver-specific exposure, with minimal effect on gene expression in extrahepatic tissues and showed an improved safety profile as compared to T3 and KB-141.
The second presentation provided data demonstrating significant total plasma cholesterol reduction when MB07811 was administered in combination with atorvastatin (Lipitor(R)) in various animal models as compared to monotherapy.
"We believe that specifically targeting a TR beta selective agonist to the liver could unlock the long-understood cholesterol reducing potential of this approach," commented Dr. Paul Laikind, president and chief executive officer. "Unwanted side effects associated with activation of thyroid hormone receptors outside the liver, including changes to the thyroid hormone axis, cardiac function, muscle metabolism and bone turnover, have hindered attempts to develop thyroid hormone agonists. With its liver-targeted properties, MB07811 could potentially overcome these previous disadvantages and provide a novel approach for treating hyperlipidemia as a monotherapy or in combination with statins."
The Company successfully completed a Phase 1a clinical trial for MB07811 at the end of 2006, which provided evidence that the candidate is safe and well tolerated when administered as a single dose. MB07811 is currently being studied in a Phase 1b multiple dose clinical trial, which is expected to be completed in the fourth quarter of 2007. This trial is a 14-day, rising dose trial in healthy volunteers with modestly elevated LDL-cholesterol levels. The clinical trial will evaluate the safety and tolerability of MB07811 in approximately 30-40 patients, and could potentially provide preliminary evidence of cholesterol-lowering activity and evidence of an improved therapeutic index, a key property that the liver-targeting is designed to address.
About Metabasis (www.mbasis.com):
Metabasis Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs to address some of the world's most widespread and costly chronic diseases. The Company has established a pipeline that includes clinical stage and preclinical product candidates targeting major diseases with significant unmet medical needs. Targeted diseases include 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(R) technologies. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and expertise.
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 pre-clinical and clinical trial results, potential safety and efficacy and further development of MB07811. 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, the progress and timing of clinical trials for Metabasis' product candidates; the fact that positive results from clinical trials does not necessarily mean later clinical trials will succeed; serious adverse side effects of, or serious adverse events related to, Metabasis' product candidates or proprietary technologies; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing Metabasis' product candidates; the potential and progress of preclinical compounds and programs; and other factors discussed in the "Risk Factors" section of Metabasis' Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. 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.
Constance Bienfait, Vice President
Investor Relations & Corporate Communications
Posted: October 2007