deCODE genetics initiates patient enrolment in the pivotal phase III trial for DG031, deCODE's lead developmental compound for the prevention of heart attack.

"In this trial we are using human genetics to take aim at the underlying biological causes of heart attack. Our approach enables us to conduct a highly sensitive study on a relatively small number of participants, focusing on a group at high identifiable risk through a pathway confirmed in many populations. Our goal is to bring forward a new drug to prevent one of the biggest indications in medicine, and we are excited to be getting underway," said Kari Stefansson, CEO of deCODE.

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 is being conducted under a Special Protocol Assessment (SPA) with the US 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.