Positive Results Announced From Trial Of DG051 For Heart Attack Prevention
deCODE genetics announced positive topline results from its Phase IIa clinical trial for DG051, the company's leukotriene A4 hydrolase inhibitor being developed for the prevention of heart attack.
With these results, the company has finalized the design of a Phase IIb trial for which it expects to begin enrolling patients this spring. The company will discuss the development of DG051 and the rest of its product portfolio in its presentation at the JP Morgan 26th Annual Healthcare Conference.
In several studies conducted in healthy volunteers last year, DG051 was shown to reduce 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 one of the factors modulating risk of heart attack.
The results of the double-blind, placebo-controlled Phase IIa study completed last month confirm that DG051 also delivers significant dose- dependent reductions in LTB4 in patients with a history of heart attack or coronary artery disease and who were taking a variety of concomitant medications. The pharmacokinetic and safety profiles of the compound were favorable and similar to those seen in previous studies in healthy volunteers. There were no serious adverse events in the study. The Phase IIb study, that will begin in the spring, will be a 400 patient, double-blind placebo- controlled study further examining its pharmacokinetic and pharmacodynamic parameters, as well as safety and tolerability.
"DG051 offers a novel approach to preventing the leading cause of death in the industrialized world. Our gene discovery work pointed us to the branch of the leukotriene pathway producing LTB4 as a major mechanism involved in promoting inflammation in atherosclerotic plaque and thereby increasing risk of heart attack. DG051 has been shown to bring this pathway under control and with a very satisfactory safety and tolerability profile. We look forward to getting our Phase IIb trial underway, and to advancing DG051 as a new approach to treating one of the major underlying causes of heart attack," said Kari Stefansson, CEO of deCODE.