Isis Initiates Phase 1 Study of ISIS 325568 Targeting Glucagon Receptor to Treat Type ...( *Isis Now Has Two Drugs From Its M...),Health

*Isis Now Has Two Drugs From Its Metabolic Disease Program In Clinical

Development

CARLSBAD, Calif., Sept. 4 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today it has initiated a Phase 1 study of ISIS 325568, an antisense drug designed to improve blood glucose control in patients with type 2 diabetes by inhibiting production of the glucagon receptor (GCGR). GCGR is a receptor that binds glucagon, a hormone that opposes the action of insulin. The Phase 1 trial of ISIS 325568 is designed to assess the drug's activity, including its effect on liver glucose production, as well as safety and pharmacokinetic profiles, providing the opportunity to demonstrate proof-of-concept in this first human trial. The study is a randomized, placebo-controlled, dose-escalation study conducted in healthy volunteers.

"We are excited by the preclinical profile of ISIS 325568, a novel first-in-class drug that has demonstrated excellent glucose control and improved pancreatic function through a dual mechanism of action in insulin-resistant animal models. Furthermore, the favorable effects on GLP-1 that we have seen exceed those observed with DPP IV inhibitors, and there was no evidence of hypoglycemia or GI side effects. These preclinical findings suggest that ISIS 325568 could offer disease modifying effects and long-term disease control both as a single agent and in combination with other diabetes treatments," said Sanjay Bhanot, M.D., Ph.D., Vice President of Metabolic Diseases Research & Development, Isis Pharmaceuticals. "In addition to demonstrating safety and tolerability in this study, we will be closely monitoring a number of biomarkers that could provide
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