deCODE genetics (Nasdaq:DCGN) 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.
About heart attack
Heart attack is the leading killer in the industrialized
world. Nearly half of men and one-third of women who
reach the age of forty will suffer a heart attack in
their lifetime. Currently, there are effective drugs
for treating some of the contributing risk factors for
heart attack but there are no existing drugs aimed at
preventing the pathogenesis of the disease itself.
About deCODE
deCODE genetics (NASDAQ:DCGN) is a global leader in
applying human genetics to develop drugs for common
diseases. Our population approach has enabled us to
discover and target key biological pathways involved
in conditions ranging from heart attack to cancer. We
are turning these discoveries into new medicine to better
treat and prevent many of the biggest challenges to
public health. 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 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.
