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news.deCODE Genetics shares have grown by almost 4% after it submitted an investigational new drug application to the FDA to move its novel anti-atherosclerosis compound, DG041, into phase I clinical testing.
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DG041 is a novel, first-in-class, orally-administered small molecule for the treatment of peripheral arterial occlusive disease (PAOD).
In pre-clinical studies, DG041 has been shown to be a selective and potent antagonist of the EP3 receptor for prostaglandin E2 (PGE2), inhibiting 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.
“DG041 represents a promising and specific new therapeutic approach to PAOD, a crippling disease with major unmet therapeutic need,” said Kari Stefansson, CEO of deCODE. “EP3 receptors may also be important modulators of pain transmission. We plan also to evaluate the potential of compounds targeting EP3 as alternatives to COX-2 inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of chronic pain.”
PAOD 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 disease is under-diagnosed, and the current mainstay of treatment is surgery to bypass the occluded vessels. At present, no drug treatment is available that targets the underlying causes of PAOD or prevents its progression.