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news.DeCode Genetics has initiated phase II clinical development program for DG041, the company's developmental compound for the treatment of peripheral artery disease, or PAD.
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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.
“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,” said Kari Stefansson, CEO of DeCode.