METABASIS COMPLETES ENROLLMENT IN TYPE 2 DIABETES STUDY

Metabasis Therapeutics has completed patient enrollment in its Phase IIb clinical trial for CS-917, a compound being developed by Daiichi Sankyo for the treatment of Type 2 diabetes pursuant to a licensing agreement between the two companies. This proof-of-concept study is designed to evaluate safety and tolerability of CS-917 after three months of dosing, as well as its effect on blood levels of the molecule HbA1c, an important measure of glucose control in patients with Type 2 diabetes, according to Metabisis.

A total of 392 patients have been enrolled at more than 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 a placebo. If successful, the trial could support selection of a dose for a pivotal Phase III clinical trial.

In two successfully completed Phase IIa clinical trials in patients with Type 2 diabetes, CS-917 was well tolerated and significantly reduced the elevated blood glucose levels that characterize the disease.

CS-917 was discovered by using Metabasis' proprietary NuMimetic technology. 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, 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.