deCODE genetics (Nasdaq:DCGN) today announced positive top-line results from its Phase I multiple dose clinical trial of DG051, which the company is developing for the prevention of
heart attack. In the study, a randomized, double-blind, multi-dose, ascending dose, placebo-controlled clinical trial, a total of 40 healthy subjects were exposed to DG051 at doses up to 320mg per day for seven days. Building upon the positive results seen in the Phase I single dose study completed at the end of last year, key results were:
Safety and tolerability: DG051 was well tolerated at all dose levels tested, with no serious adverse events reported.
Dose-dependent reduction of leukotriene B4 (LTB4): DG051 was shown to reduce LTB4 production in a dose-dependent manner, with a peak reduction of more than 70% versus baseline after 7 days of treatment.
Pharmacokinetic profile: DG051 was found to have good bioavailability, with low variability between subjects. With a terminal half-life of approximately 9 hours and measurable concentrations at 24 hours after dosing, DG051 has a pharmacokinetic profile suitable for once-a-day dosing.
“The results of our Phase I trials show DG051 to be well tolerated and to provide a potent means of reining in the activity of the pathway our research has shown to modulate risk of heart attack. This latest study also provides us with pharmacodynamic data suggesting that we may be able to achieve a high steady-state reduction in LTB4 production with a dose in the middle of the range we have tested, and we look forward to entering DG051 into Phase II trials later this year,” 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 being developed for the prevention of heart attack. LTA4H is encoded by one of the genes in the leukotriene pathway 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 leukotriene B4 (LTB4). DG051 is designed to decrease risk of heart attack by decreasing the production of LTB4.
deCODE genetics (Nasdaq:DCGN) 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.