DEVELOPMENT OF DRUG FOR TYPE 2 DIABETES TO RESUME

Sankyo and Metabasis Therapeutics jointly announced that Sankyo plans to resume full development of CS-917, including a Phase IIb clinical trial expected to begin in the fourth quarter. CS-917 is a first-in-class orally active, gluconeogenesis inhibitor that has shown promise as a treatment for patients with Type 2 diabetes.

A Phase IIb study evaluating CS-917 was halted earlier this year after two serious adverse events occurred during a Phase I study that combined CS-917 with the diabetes drug metformin. After a comprehensive review of the program and the events and data surrounding the two serious adverse events, Sankyo has concluded that full development, including a Phase IIb clinical trial, can safely resume.

CS-917 is the first of a new therapeutic class discovered by Metabasis that are designed to potently and selectively inhibit the gluconeogenesis pathway. This pathway is responsible for the abnormal overproduction of glucose in the liver of patients with Type 2 diabetes mellitus. Thus, by specifically inhibiting this pathway, liver glucose production should be reduced and blood sugar levels decreased.