REYKJAVIK, Iceland, May 01, 2007 /PRNewswire-FirstCall/ -- deCODE genetics 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