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.
About deCODE
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.
