May 3, 2006
deCODE genetics (Nasdaq:DCGN) today announced that it has reached an agreement with the US Food and Drug Administration (FDA) on the design of its Phase III clinical trial for DG031, deCODE’s lead developmental compound for the prevention of heart attack. The Special Protocol Assessment (SPA) enables deCODE to proceed with the recruitment of participants for the Phase III trial. The SPA is an agreement between the FDA and deCODE on the objectives, design, primary endpoints and statistical analysis plan for the trial. Achievement of the pre-specified endpoints would fulfill requirements to support regulatory approval for a new drug application (NDA) for DG031.
“We are very pleased to have an SPA for the Phase III clinical trial of DG031, and are on track to enroll our first patients within the coming weeks. The design of this trial represents a powerful use of human genetics in the drug development process which enhances the likelihood of success. We have retained CROs to help us to execute the trial, and are in the process of initiating more than 100 study sites and have manufactured more than three million tablets. We are ready to begin,” said Kari Stefansson, CEO of deCODE.
The multicenter Phase III trial will be randomized, double blind, placebo controlled, and will enroll approximately 3000 patients with a history of recent heart attack. The trial, referred to as the Leukotrienes in Coronary Artery Disease study, or LTCAD, will focus on the group at highest identifiable risk of heart attack through the pathway targeted by DG031. 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.
deCODE is a biopharmaceutical company applying its discoveries in human genetics to the development of drugs for common diseases. deCODE is a global leader in gene discovery – our population approach and resources have enabled us to isolate key genes contributing to major public health challenges from cardiovascular disease to cancer, genes that are providing us with drug targets rooted in the basic biology of disease. deCODE is also leveraging its expertise in human genetics and integrated drug discovery and development capabilities to offer innovative products and services in DNA-based diagnostics, bioinformatics, genotyping, structural biology, drug discovery and clinical development. deCODE is delivering on the promise of the new genetics.SM Visit us on the web at www.decode.com.
Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results, and the timing of events, to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, integration of acquired businesses, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in deCODE’s filings with the Securities and Exchange Commission. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.