deCODE starts Phase II clinical testing of DG051

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 favorable 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 said that it will use the results from this study to inform dose selection for a larger Phase IIb trial planned to commence early next year.

Kari Stefansson, CEO of deCODE said: “We are advancing DG051 as a novel means of preventing heart attack, the leading cause of death in the industrialized world. We are excited to have begun testing its potential in patients.”