WASHINGTON, May 17 (UPI) -- deCODE said Wednesday it is launching a phase 3 study of a gene-based treatment aimed at preventing heart attack.
The company said it is beginning to enroll patients in the multi-center trial, which will ultimately enroll about 3,400 patients who have had a recent heart attack.
The trial -- dubbed the Leukotrienes in Coronary Artery Disease -- will focus on the group at highest risk of heart attack via the pathway that DGO31 targets: African-Americans who carry an at-risk variant of one of the genes linked to risk of heart attack through the leukotriene pathway.
The study will also include patients without this gene variant, the company said.
The trial -- using a dose of 500mg of DG031 twice daily -- will primarily measure reduction in fatal and non-fatal heart attack and stroke, hospitalization for unstable angina and the need for urgent revascularization.
The duration of the study will depend on the number of cardiac events seen in the study group, deCODE said.
"This is an important study for deCODE and a small milestone in the history of drug development. In this trial we are using human genetics to take aim at the underlying biological causes of heart attack," said deCODE Chief Executive Officer Kari Stefansson. "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."
DG031 works by inhibiting the 5-lipoxygenase activating protein, or FLAP. deCODE has linked variants in the gene encoding FLAP and the gene encoding leukotriene A4 hydrolase (LTA4H) to heart-attack risk.
