Enrollment opens in Ph II trial of deCODE's DG051

Iceland's deCODE genetics has begun enrolling patients in a Phase IIa trial of DG051, its leukotriene A4 hydrolase inhibitor being developed for the prevention of heart attack.

In Phase I studies completed earlier this year, the agent significantly reduced the production of leukotriene B4 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 favorable pharmacokinetic profile, the firm noted, adding that 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 on these findings by evaluating the effect of DG051 in patients with a history of heart attack or coronary artery disease. The randomized, double-blind, placebo-controlled trial 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 start early next year.