deCODE Initiates Phase III Trial for DG031 for the Prevention of Heart Attack
Wednesday May 17, 4:01 pm ET
Pioneering use of human genetics to target the causative biology of the leading cause of death in the industrialized world
REYKJAVIK, Iceland, May 17 /PRNewswire-FirstCall/ -- deCODE genetics (Nasdaq: DCGN - News) today 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.
"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. 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 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).
About DG031
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. In Phase II trials completed last year, DG031 was shown to be well tolerated at all doses tested and to reduce the production of LTB4 in a dose-dependent manner. Late last year deCODE discovered that the HapK variant of the LTA4H gene, discovered in Iceland and which confers a moderate increase in risk of heart attack in people of predominantly European ancestry, confers a 250% increase in risk of the disease in African Americans. deCODE licensed DG031 from Bayer AG, which developed it originally for the treatment of asthma. In deCODE's clinical trials and those conducted previously by Bayer, a total of approximately 2000 people have been dosed with DG031. |
