SAN DIEGO, Feb. 1 /PRNewswire-FirstCall/ -- Metabasis Therapeutics today announced that enrollment was recently completed in the ongoing Phase 2b clinical trial for CS-917, a compound being developed for the treatment of type 2 diabetes by Daiichi Sankyo pursuant to a licensing agreement between the two companies. This proof-of-concept study is designed to evaluate safety and tolerability after three months of dosing of CS-917, as well as its effect on blood levels of the molecule HbA1c, an important measure of glucose control in patients with type 2 diabetes.
A total of 392 patients have been enrolled at over 100 sites in this randomized, double-blind, placebo controlled trial. Patients are evenly distributed among four groups consisting of two active dose groups of CS-917, an active comparator and placebo. If successful, the trial could support selection of a dose for a pivotal Phase 3 clinical trial.
In two successfully completed Phase 2a clinical trials (14-day and 28-day) in patients with type 2 diabetes, CS-917 was well tolerated and significantly reduced the elevated blood glucose levels that characterize the disease. The results from the 14-day Phase 2a clinical trial involving 39 patients were presented at the 2006 American Diabetes Association meeting and showed that oral administration of CS-917 in the morning resulted in significant lowering of post-dose fasting plasma glucose (FPG) compared to placebo. This study was followed by a 28-day study in 146 type 2 diabetic patients which indicated that CS-917 was most likely to be administered twice daily.
“The completion of patient enrollment in this trial is another step forward in the development of this novel compound, designed to inhibit gluconeogenesis, for patients suffering from type 2 diabetes,” stated Dr. Paul Laikind, president and chief executive officer of Metabasis. “With an estimated 180 million people worldwide with type 2 diabetes and with the incidence continuing to grow, new treatment options are urgently needed as current therapies often only achieve modest reduction in the production of glucose. We believe that CS-917 is the first of a new therapeutic class that has the potential to be an important distinctive approach for treating patients who suffer from type 2 diabetes.”
Dr. Mark Erion, executive vice president of research and development and chief scientific officer at Metabasis, commented. “CS-917 acts as a direct inhibitor of the pathway in the liver responsible for the production of glucose, the gluconeogenesis pathway. CS-917 is being evaluated to determine whether it may be used alone or in combination with certain other drugs designed to enhance removal of glucose from the bloodstream, and for the large number of patients who are unable to take metformin, a treatment currently used as first line therapy in patients with type 2 diabetes.”
About CS-917:
CS-917 is a compound for the treatment of type 2 diabetes that was discovered by using Metabasis’ proprietary NuMimetic(TM) technology, and is being developed by Daiichi Sankyo pursuant to a licensing agreement between Metabasis and Daiichi Sankyo. Metabasis retains co-promotion rights in North America. CS-917 is a prodrug of an orally active, potent and selective inhibitor of fructose-1, 6-bisphosphatase (FBPase), a regulatory enzyme in the pathway responsible for the production of glucose in the liver, known as the gluconeogenesis pathway. By specifically inhibiting this pathway, liver glucose production should be reduced and blood sugar levels decreased in patients with diabetes, independent of insulin levels, body weight and disease stage. Metabasis believes that CS-917 is the first product candidate to be studied in human clinical trials that is designed to directly block this pathway.
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 potential success of the Phase 2b clinical trial for CS-917 as well as the potential use and efficacy of CS-917. 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; 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 risks and uncertainties discussed in the “Risk Factors” section of Metabasis’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2006 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.
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 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(R) technologies. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and expertise.
Metabasis Therapeutics, Inc.
CONTACT: Constance Bienfait, Vice President, Investor Relations &Corporate Communications of Metabasis Therapeutics, Inc., MetabasisTherapeutics, Inc., +1-858-622-5575
Web site: http://www.mbasis.com/
