A total of 196 healthy subjects have been exposed to DG041 at doses up to 1600 mg per day for seven days. As well as the encouraging safety profile of the drug, DG041 was shown to produce a dose-dependent reduction in platelet aggregation after stimulation with collagen and sulprostone, an agonist of prostaglandins E2 (PGE2).
Peripheral artery disease (PAD) is a vascular disorder that affects over 10% of the adult population in the industrialized world and one in five people over the age of 70. The initial symptoms include intermittent pain in the legs while walking or exercising, due to the narrowing by atherosclerotic plaques of one or more major arteries in the legs. The reduction of blood flow leads to insufficient oxygenation of muscle tissue.
“We are very encouraged by the data coming out of our phase I program and are well on track with our plans to begin phase II. An oral compound that inhibits platelet aggregation without increasing bleeding time is indeed exciting,” said Kari Stefansson, CEO of DeCode.