deCODE Initiates Phase III Trial for DG031 for the Prevention of Heart Attack

Pioneering use of human genetics to target the causative biology

19-May-2006

deCODE genetics announced the initiation of patient enrollment in the pivotal Phase III trial for DG031, deCODE's lead developmental compound for the prevention of heart attack.

The multicenter Phase III trial will be randomized, double-blind, placebo-controlled, and will enroll 3400 patients with a history of recent heart attack. The trial, the Leukotrienes in Coronary Artery Disease, or LTCAD study, will focus on the group at highest identifiable risk of heart attack through the pathway targeted by DG031: African-American heart patients who carry an at-risk variant of one of the genes deCODE has linked to risk of heart attack through the leukotriene pathway. The trial will also include patients without the at-risk variant. The trial will evaluate a dose of 500mg of DG031 twice daily, and the primary endpoint is a composite of reduction in fatal and non-fatal heart attack and stroke, hospitalization for unstable angina, and the need for urgent revascularization. The duration of the trial will be driven by the number of cardiac events seen in the study group. An interim analysis is planned once half the target number of events has been reached. The trial is being conducted under a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA).

DG031 is an inhibitor of 5-lipoxygenase activating protein, or FLAP. deCODE has linked variants in the gene encoding FLAP, and the gene encoding leukotriene A4 hydrolase (LTA4H) to risk of heart attack. These variants appear to confer increased risk of heart attack by increasing the production of leukotriene B4 (LTB4), a potent driver of inflammation produced in atherosclerotic plaques.

https://www.bionity.com/en/news/54894/decode-initiates-phase-iii-trial-for-dg031-for-the-prevention-of-heart-attack.html