deCODE Successfully Completes Phase I Clinical Program for DG041 for the Treatment of Peripheral Artery Disease
deCODE genetics announced top-line results from Phase I clinical studies of DG041, the company's developmental compound for the treatment of peripheral artery disease (PAD). The company has completed the phase I studies of DG041 and expects to begin a Phase II clinical trial before mid-year.
DG041 is a 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.
To date, a total of 196 healthy subjects have been exposed to DG041 at doses up to 1600mg per day for seven days. DG041 was found to be well tolerated at all dose levels tested, with no drug-related serious adverse events noted.DG041 provided a dose-dependent reduction in platelet aggregation after stimulation with collagen and sulprostone, an agonist of prostaglandins E2 (PGE2). Doses that maximally inhibit platelet aggregation were identified. No significant changes in bleeding time and no significant changes in platelet-function assay (PFA-100) results were observed between subjects on DG041 versus those on placebo.
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