deCODE genetics (Nasdaq:DCGN) today
announced top-line results from Phase I clinical studies of DG041, the
company's developmental compound for the treatment of peripheral artery
disease (PAD). The company has completed the Phase I studies of DG041
and expects to begin a Phase II clinical trial before mid-year.
To date, a total of 196 healthy subjects have been exposed to DG041
at doses up to 1600mg per day for seven days. Among the key results of
the Phase I program are:
Safety and tolerability: DG041 was found to be well tolerated at all
dose levels tested, with no drug-related serious adverse events noted.
Inhibition of platelet aggregation: DG041 provided a dose-dependent
reduction in platelet aggregation after stimulation with collagen and
sulprostone, an agonist of prostaglandins E2 (PGE2). Doses that
maximally inhibit platelet aggregation were identified.
Effect on bleeding time: No significant changes in bleeding time and
no significant changes in platelet-function assay (PFA-100) results
were observed between subjects on DG041 versus those on placebo.
"We are very encouraged by the data coming out of our Phase I
program and are well on track with our plans to begin Phase II. An oral
compound that inhibits platelet aggregation without increasing bleeding
time is indeed exciting. I think also that our chemistry unit has
continued to do stellar work in this program. Last fall they succeeded,
in a matter of weeks, in coming up with a new formulation of DG041 that
greatly improved bioavailability. From the discovery of a gene linked
to PAD to where we are today, we have probably cut the
industry-standard timeline for drug discovery and development in half,"
said Kari Stefansson, CEO of deCODE.
About DG041
DG041 is a novel, first-in-class,
orally-administered small molecule developed by deCODE that the company
has shown to be a selective and potent antagonist of the EP3 receptor
for PGE2. deCODE identified EP3 as a target through the company's
population genetics research, which led to the discovery of variants in
the gene encoding EP3 that confer risk of PAD.
About PAD
Peripheral
artery disease is a vascular disorder that affects over 10% of the
adult population in the industrialized world and one in five people
over the age of 70. The initial symptoms include intermittent pain in
the legs while walking or exercising, due to the narrowing by
atherosclerotic plaques of one or more major arteries in the legs. The
reduction of blood flow leads to insufficient oxygenation of muscle
tissue. As the disease worsens it can lead to tissue damage, ulceration
and gangrene, and in extreme cases may require the amputation of the
affected limb. The disease is under-diagnosed, and the current mainstay
of treatment is surgery to bypass the occluded vessels. At present, no
drug treatment is available that targets the underlying causes of PAD
or prevents its progression.
About deCODE
deCODE genetics (Nasdaq:DCGN) 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 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.
