deCODE genetics has reported 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 the results, the Reykjavik, Iceland-based company said it has finalized the design of a Phase IIb trial for which it expects to begin enrolling patients this spring.
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, deCODE reported. LTB4 is a pro-inflammatory molecule that deCODE identified as a one of the factors modulating risk of heart attack.
The company said that the results of the double-blind, placebo-controlled Phase IIa study completed last month confirm that DG051 delivers significant dose-dependent reductions in LTB4 in patients with a history of heart attack or coronary artery disease, including those who were taking a variety of concomitant medications. The pharmacokinetic and safety profiles were favorable and similar to those seen in previous studies in healthy volunteers, and there were no serious adverse events in the study, deCODE said.
The Phase IIb study, which 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, deCODE reported.