Metabasis Therapeutics Presents the Discovery of Its Second-Generation FBPase Inhibitor, MB07803, at the 235th American Chemical Society National Meeting
The presentation discussed the discovery of its second-generation FBPase inhibitor, MB07803, which was designed to improve upon CS-917, the Company's first-generation product candidate in the FBPase inhibitor class. The presentation also provided details from several preclinical studies, as well as pharmacokinetic data from a Phase 1, rising single-dose clinical trial, conducted in healthy volunteers. In addition, the presentation highlighted the design strategy pursued by the Company that led to the discovery of MB07803, as well as the key differentiating factors between MB07803 and CS-917.
As discussed in the presentation, in studies conducted in animals, MB07803 showed higher oral bioavailability, reduced metabolism and increased potency as compared with CS-917, improvements that supported the selection of MB07803 for clinical development. In the Phase 1 clinical trial, MB07803 showed a promising pharmacokinetic profile consistent with the preclinical data. Moreover, the pharmacokinetic data from the Phase 1 clinical trial supported once-a-day dosing, a reduced frequency of dosing relative to CS-917.
MB07803 is designed to block the metabolic pathway in the liver that results in excessive glucose production in patients with type 2 diabetes. Excess hepatic glucose production is believed to be a major contributing factor to the elevated glucose levels associated with increased morbidity and mortality in patients with type 2 diabetes. MB07803 is currently in a Phase 2a, 28-day proof-of-concept clinical trial. Metabasis has completed enrollment of the study including over 100 patients and is on track to deliver top-line results for this clinical trial later in the second quarter of 2008.
"We were very pleased to be invited to present at such a prestigious symposium as the ACS national meeting and equally pleased to be included in the upcoming meeting coverage in Chemical & Engineering News," commented Dr. Mark Erion, executive vice president of research and development and chief scientific officer. "Our presentation at the ACS meeting represents the Company's first public scientific disclosure of the structure of MB07803 and its glucose-lowering activity in preclinical animal models. The presentation also detailed the candidate's key differentiating factors as compared to CS-917, our first-generation FBPase inhibitor. Importantly, the pharmacokinetic data from our Phase 1 clinical trials appear consistent with the preclinical results and the differences predicted from those results between MB07803 and CS-917. We look forward to reviewing key data from our ongoing Phase 2a clinical trial later this quarter that will provide an initial assessment of the safety and glucose-lowering properties of MB07803 in patients with type 2 diabetes."
About Type 2 Diabetes:
Diabetes is a rapidly growing, worldwide health crisis. According to the International Diabetes Federation, in 2006, the number of patients suffering with diabetes worldwide reached over 200 million, or nearly 6 percent of the world's population, with treatment and prevention costs reaching approximately $232 billion. Approximately 90% of patients with diabetes worldwide have type 2 diabetes. According to the American Diabetes Association, diabetes is the fastest growing disease in the U.S. In 2007, approximately 20 million Americans, or 7% of the U.S. population, were afflicted with diabetes, with costs associated with the disease reaching $174 billion.
About Metabasis (www.mbasis.com):
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 and diabetes, 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 product candidates were developed internally using proprietary technologies.
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; and the design, potential efficacy and benefits of, and the potential market for MB07803. 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' Annual Report on Form 10-K for the fiscal year ended December 31, 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.
Metabasis Therapeutics, Inc.
Investor Relations & Corporate Communications
Posted: April 2008