deCODE genetics (Nasdaq:DCGN) today announced the
initiation of the Phase II clinical development program for DG041, the company’s
developmental compound for the treatment of peripheral artery disease, or
PAD. The company has begun patient enrollment in a Phase IIa trial that will
examine safety and tolerability, dosing, and the effect of different dose
levels on platelet function and a range of serum biomarkers associated with
atherosclerosis.
The trial will be randomized, double-blind, placebo-controlled, and will
enroll approximately 150 patients with intermittent claudication due to PAD.
The cohort will be divided evenly into three groups: one receiving the 100mg
twice daily, another receiving 400mg twice daily, and the third receiving
placebo. The trial will enroll both patients with and without the gene variants
that deCODE has linked to risk of PAD. Treatment will last four weeks.
“In our clinical work to date DG041 has been shown to be a very promising
compound and I am pleased to announce that we have now brought it into Phase
II. This is a first-in-class compound developed by our chemists based upon
our discoveries in human genetics. It represents a truly pioneering effort
to bring forward a treatment for PAD that specifically targets the disease
process. PAD affects tens of millions of people in the industrialized world
alone, making DG041 a medically and commercially important component of our
pipeline of new drugs for major diseases.” 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. In the Phase
I clinical program, DG041 was found to be well tolerated at all dose levels
tested; to provide a dose-dependent reduction in platelet aggregation after
stimulation with collagen and sulprostone, and to do so without any significant
changes in bleeding time.
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 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.
