FDAnews
www.fdanews.com/articles/67657-decode-submits-ind-for-novel-anti-atherosclerosis-compound-dg041

DECODE SUBMITS IND FOR NOVEL ANTI-ATHEROSCLEROSIS COMPOUND DG041

January 17, 2005

deCODE genetics has submitted an investigational new drug application to the FDA for DG041, a novel, first-in-class, orally administered small molecule for the treatment of peripheral arterial occlusive disease (PAOD).

In preclinical studies, DG041 has been shown to be a selective and potent antagonist of the EP3 receptor for prostaglandin E2 (PGE2), inhibiting, in a dose-dependent manner, human platelet aggregation induced in vitro by PGE2.

deCODE identified EP3 as a target in PAOD through its population genetics research, which linked variations in the gene encoding EP3 to a significantly increased risk of the disease. Pending clearance by the FDA, deCODE intends to initiate a Phase I clinical trial of DG041 this spring.