deCODE Initiates Phase II Clinical Program for DG041 for Peripheral Artery Disease
Thursday June 22, 8:11 am ET
REYKJAVIK, Iceland, June 22 /PRNewswire-FirstCall/ -- deCODE genetics (Nasdaq: DCGN - News) today announced the initiation of the Phase II clinical development program for DG041, the company's developmental compound for the treatment of peripheral artery disease, or PAD. The company has begun patient enrollment in a Phase IIa trial that will examine safety and tolerability, dosing, and the effect of different dose levels on platelet function and a range of serum biomarkers associated with atherosclerosis.
The trial will be randomized, double-blind, placebo-controlled, and will enroll approximately 150 patients with intermittent claudication due to PAD. The cohort will be divided evenly into three groups: one receiving the 100mg twice daily, another receiving 400mg twice daily, and the third receiving placebo. The trial will enroll both patients with and without the gene variants that deCODE has linked to risk of PAD. Treatment will last four weeks.
"In our clinical work to date DG041 has been shown to be a very promising compound and I am pleased to announce that we have now brought it into Phase II. This is a first-in-class compound developed by our chemists based upon our discoveries in human genetics. It represents a truly pioneering effort to bring forward a treatment for PAD that specifically targets the disease process. PAD affects tens of millions of people in the industrialized world alone, making DG041 a medically and commercially important component of our pipeline of new drugs for major diseases." said Kari Stefansson, CEO of deCODE.
About DG041
DG041 is a novel, first-in-class, orally-administered small molecule developed by deCODE that the company has shown to be a selective and potent antagonist of the EP3 receptor for PGE2. deCODE identified EP3 as a target through the company's population genetics research, which led to the discovery of variants in the gene encoding EP3 that confer risk of PAD. In the Phase I clinical program, DG041 was found to be well tolerated at all dose levels tested; to provide a dose-dependent reduction in platelet aggregation after stimulation with collagen and sulprostone, and to do so without any significant changes in bleeding time. |
