June 29, 2006
deCODE genetics (Nasdaq: DCGN) today announced that it has submitted an investigational new drug application (IND) to the US Food and Drug Administration (FDA) for DG051, the company’s follow-on investigational compound for the prevention of heart attack. Pending clearance by the FDA, the company expects to begin Phase I clinical testing of the compound later this summer.
“Through our gene discovery work we have developed a new understanding of the role of the leukotriene pathway in modulating the risk of heart attack. We now have two compounds in clinical development designed to control this pathway, programs which are landmarks in the advancement of novel means to combat the leading cause of death in the industrialized
world. With DG031 in Phase III, bringing forward DG051 is an important component of deCODE’s strategy to deliver on the therapeutic and commercial potential of targeting this pathway, leveraging our solid intellectual property position both swiftly and well into the future,” said Kari Stefansson, CEO of deCODE.
DG051 is a novel small-molecule inhibitor of leukotriene A4 hydrolase (LTA4H), the protein made by one of the genes in the leukotriene pathway deCODE has linked to risk of heart attack. Like DG031, the company’s lead compound for the prevention of heart attack now in a Phase III clinical trial, DG051 is designed to decrease risk of heart attack by decreasing the
production of leukotriene B4 (LTB4), an end product of the leukotriene pathway and a potent promoter of inflammation. DG051 was discovered by deCODE’s structural biology and chemistry groups, and in preclinical studies it has been shown in human blood ex vivo and in animal models to be a potent inhibitor of LTB4 production.
deCODE genetics (NASDAQ:DCGN) is a global leader in applying human genetics to develop drugs for common diseases. Our population approach has enabled us to discover and target key biological pathways involved in conditions ranging from heart attack to cancer. We are turning these discoveries into new medicine to better treat and prevent many of the biggest challenges to public health. deCODE is delivering on the promise of the new genetics.SM Visit us on the web at www.decode.com.
Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, integration of acquired businesses, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in deCODE’s filings with the Securities and Exchange Commission. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.