European Patent Granted for the Small-Molecule 4SC-101
December 01 2009 - 2:00AM
Business Wire
4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and
development company, today announced that the European Patent
Office has granted patent EP1392642, which covers its lead
auto-immune compound 4SC-101. This small molecule is a DHODH and
IL-17 inhibitor which is currently in Phase II trials in rheumatoid
arthritis and inflammatory bowel disease.
The patent, entitled “novel compounds as anti-inflammatory,
immunomodulatory and anti-proliferatory agents” protects the
manufacturing, composition of matter and use in diseases of a novel
group of compounds which inhibit DHODH, including 4SC-101. 4SC has
already obtained a patent for 4SC-101 from the United States Patent
and Trademark office, which was issued in 2006. In addition,
patents have been granted in Canada, Russia, New Zealand, South
Africa and Mexico.
Ulrich Dauer, CEO of 4SC, commented: “We are pleased to have now
received a European patent to cover the composition of matter of
our lead auto-immune compound 4SC-101, in addition to the already
granted US patent, securing us complete protection of exclusivity
and freedom to operate. We look forward to an exciting year in
2010, as we are expecting clinical results for this small-molecule
in an exploratory Phase IIa study in inflammatory bowel disease, as
well as in a Phase IIb study in rheumatoid arthritis, firmly
positioning us in the small-molecule space within these growing
indications.”
About 4SC-101
4SC-101 is a novel, orally administered small molecule that is
classified as a synthetic DMARD as it aims to slow the disease
progression of rheumatoid arthritis. The compound also has broad
therapeutic potential in other autoimmune diseases such as
inflammatory bowel disease, multiple sclerosis and psoriasis.
4SC-101 inhibits dihydroorotate dehydrogenase (DHODH), which acts
as a highly selective inhibitor of the biosynthesis of pyrimidines,
thereby halting the proliferation of rapidly multiplying cells, in
particular of lymphocytes which are involved in the pathology of
autoimmune disorders. 4SC also recently demonstrated in
pre-clinical tests that 4SC-101 inhibits the expression of IL-17, a
pro-inflammatory cytokine that has a pathogenic role in autoimmune
disorders.
About Rheumatoid Arthritis
Rheumatoid Arthritis is a chronic inflammatory joint disease
that afflicts 0.5 - 1% of the population; women are three times
more likely to get arthritis than men. In the late stage of the
disease, irreversible damage to joint cartilage and bones occurs.
Causes of this disease are genetic as well as autoimmune factors.
Besides pain-relieving medicines, so-called disease-modifying
medicines (DMARDs = disease modifying anti-rheumatic drugs) can be
used in treatment. They differ from other groups of drugs used in
the treatment of rheumatoid diseases, since only they are able to
stop or reduce damage caused from chronic inflammation to the joint
cartilage or bone. In the most favourable cases, some DMARDs can
also induce repair of damage to joints and provide support for the
repair of changes that have already occurred. DMARDS can be
synthetic small molecules or antibodies.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a group of inflammatory
conditions of the gastrointestinal tract. The main forms of IBD are
Crohn's disease and ulcerative colitis, chronic diseases which are
constituted by acute-disease flare ups and symptom-free phases. IBD
patients suffer from abdominal pain, rectal bleeding, diarrhea,
weight loss, fatigue and other extra-intestinal symptoms. Although
the causes of IBD are not completely understood, it is assumed that
a disregulated immune response results in inflammatory mediators,
such as IL-17, that attack the patient’s intestinal mucosa and
trigger the symptoms. Crohn’s disease is characterised by an
inflammatory affliction of part of or the whole digestive tract,
while ulcerative colitis is a disease of the colon and the rectum
only. IBD leads to a considerable reduction in quality of life, but
may also involve severe complications requiring immediate surgery.
Current therapeutic options for patients are largely limited to the
use of anti-inflammatory steroids applied either systemically or
locally for the treatment of the symptoms, as well as biological
(anti-TNF-alpha) agents.
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development
company focused on autoimmune and cancer indications. The company
currently has three clinical programs, with three further clinical
trials planned to commence in 2009. 4SC-101, a small molecule, is
in a Phase IIb study in rheumatoid arthritis as well as in a Phase
IIa exploratory study in inflammatory bowel disease. The company’s
lead oncology compound, 4SC-201, a histone deacetylase (HDAC)
inhibitor, is in a Phase II trial in hepatocellular carcinoma and
is due to commence a further Phase II trial in Hodgkin’s lymphoma
in 2009. Drug candidates are developed until proof-of-concept in
order to generate value creating partnerships with the
pharmaceutical industry in return for advance and milestone
payments as well as royalties.
4SC was founded in 1997, has 93 employees, and is listed on the
Prime Standard of the Frankfurt Stock Exchange since December
2005.
For further information please visit www.4sc.com.
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plans and objectives relating to our future operations, products,
or services; future financial results; or assumptions underlying or
relating to any such statements; each of which constitutes a
forward-looking statement subject to risks and uncertainties, many
of which are beyond our control. Actual results could differ
materially, depending on a number of factors.
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