deCODE genetics, Inc. Launches Phase II Clinical Testing of DG051 for the Prevention of Heart Attack
REYKJAVIK, Iceland, Oct. 9 /PRNewswire-FirstCall/ -- deCODE genetics today announced that it has begun enrolling patients for its Phase IIa clinical trial for DG051, the company's leukotriene A4 hydrolase inhibitor being developed for the prevention of heart attack.
In Phase I studies completed earlier this year, DG051 significantly reduced the production of leukotriene B4 (LTB4) in a dose dependent manner. LTB4 is a pro-inflammatory molecule that deCODE's gene discovery and functional biology work identified as a key factor in modulating risk of heart attack. The Phase I studies showed DG051 to be safe and well-tolerated at all dose levels tested, with a favourable pharmacokinetic profile. DG051 was also recently evaluated in a 28-day Phase I study that further demonstrated that the drug can deliver significant, sustained reductions in LTB4 levels with once-daily dosing.
The design of the Phase IIa study is based upon these findings by studying the effect of DG051 in patients with a history of heart attack or coronary artery disease. The Phase IIa is a randomized, double-blind, placebo- controlled trial that will examine the impact of DG051 on the production of LTB4 as well as the compound's pharmacokinetic and safety and tolerability profiles in heart patients. The company will use the results from this study to inform dose selection for a larger Phase IIb trial planned to commence early next year.
"We are advancing DG051 as a novel means of preventing heart attack, the leading cause of death in the industrialized world. Our clinical studies thus far have shown that it effectively reins in the activity of a branch of the leukotriene pathway that has been linked to risk of heart attack, and it has demonstrated a solid safety and pharmacokinetic profile. The 28-day study we just completed shows that DG051 can achieve good reductions in leukotriene B4 levels with once-daily dosing. We are excited to have begun testing its potential in patients," said Kari Stefansson, CEO of deCODE.
DG051 is a first-in-class, small-molecule inhibitor of leukotriene A4 hydrolase (LTA4H) discovered by deCODE's chemistry unit and is being developed for the prevention of heart attack. LTA4H is encoded by one of the genes deCODE has linked to increased risk of heart attack. The at-risk versions of these genes confer increased risk of heart attack by increasing the production of the pro-inflammatory molecule LTB4. DG051 is designed to decrease risk of heart attack by decreasing the production of LTB4.
deCODE genetics is a global leader in applying human genetics to develop drugs and diagnostics 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, and on our diagnostics site at www.decodediagnostics.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.
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