deCODE genetics
(Nasdaq: DCGN) announced that it has begun enrolling patients for its
Phase IIa clinical trial for DG051, the company's leukotriene A4 hydrolase
inhibitor being developed for the prevention of heart attack.
In Phase I studies completed earlier this year, DG051 significantly
reduced the production of leukotriene B4 (LTB4) in a dose dependent manner.
LTB4 is a pro-inflammatory molecule that deCODE's gene discovery and
functional biology work identified as a key factor in modulating risk of
heart attack. The Phase I studies showed DG051 to be safe and
well-tolerated at all dose levels tested, with a favourable pharmacokinetic
profile. DG051 was also recently evaluated in a 28-day Phase I study that
further demonstrated that the drug can deliver significant, sustained
reductions in LTB4 levels with once-daily dosing.
The design of the Phase IIa study is based upon these findings by
studying the effect of DG051 in patients with a history of heart attack or
coronary artery disease. The Phase IIa is a randomized, double-blind,
placebo- controlled trial that will examine the impact of DG051 on the
production of LTB4 as well as the compound's pharmacokinetic and safety and
tolerability profiles in heart patients. The company will use the results
from this study to inform dose selection for a larger Phase IIb trial
planned to commence early next year.
"We are advancing DG051 as a novel means of preventing heart attack,
the leading cause of death in the industrialized world. Our clinical
studies thus far have shown that it effectively reins in the activity of a
branch of the leukotriene pathway that has been linked to risk of heart
attack, and it has demonstrated a solid safety and pharmacokinetic profile.
The 28-day study we just completed shows that DG051 can achieve good
reductions in leukotriene B4 levels with once-daily dosing. We are excited
to have begun testing its potential in patients," said Kari Stefansson, CEO
of deCODE.
About DG051
DG051 is a first-in-class, small-molecule inhibitor of leukotriene A4
hydrolase (LTA4H) discovered by deCODE's chemistry unit and is being
developed for the prevention of heart attack. LTA4H is encoded by one of
the genes deCODE has linked to increased risk of heart attack. The at-risk
versions of these genes confer increased risk of heart attack by increasing
the production of the pro-inflammatory molecule LTB4. DG051 is designed to
decrease risk of heart attack by decreasing the production of LTB4.
About deCODE
deCODE genetics (Nasdaq: DCGN) is a global leader in applying human
genetics to develop drugs and diagnostics 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 decode,
and on our diagnostics site at decodediagnostics.
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.
deCODE genetics
decode
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