deCODE genetics (Nasdaq:DCGN) today announced positive top-line
results from its Phase I multiple dose clinical trial of
DG051, which the company is developing for the prevention
of
heart attack. In the study, a randomized, double-blind,
multi-dose, ascending dose, placebo-controlled clinical trial,
a total of 40 healthy subjects were exposed to DG051 at doses
up to 320mg per day for seven days. Building upon the positive
results seen in the Phase I single dose study completed at
the end of last year, key results were:
Safety and tolerability: DG051 was well tolerated at all
dose levels tested, with no serious adverse events reported.
Dose-dependent reduction of leukotriene B4 (LTB4): DG051
was shown to reduce LTB4 production in a dose-dependent manner,
with a peak reduction of more than 70% versus baseline after
7 days of treatment.
Pharmacokinetic profile: DG051 was found to have good bioavailability,
with low variability between subjects. With a terminal half-life
of approximately 9 hours and measurable concentrations at
24 hours after dosing, DG051 has a pharmacokinetic profile
suitable for once-a-day dosing.
“The results of our Phase I trials show DG051 to be well
tolerated and to provide a potent means of reining in the
activity of the pathway our research has shown to modulate
risk of heart attack. This latest study also provides us
with pharmacodynamic data suggesting that we may be able
to achieve a high steady-state reduction in LTB4 production
with a dose in the middle of the range we have tested, and
we look forward to entering DG051 into Phase II trials later
this year,” 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 being developed for the prevention of heart attack.
LTA4H is encoded by one of the genes in the leukotriene
pathway 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 leukotriene B4 (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 www.decode.com, and on our diagnostics site at www.decodediagnostics.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.
