4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and
development company focused on autoimmune and cancer indications,
today announced positive preliminary results of a Phase IIa study
in inflammatory bowel disease (IBD) with its lead autoimmune
compound vidofludimus, an oral inhibitor of interleukin-17 (IL-17)
release. The exploratory, open-label, single-arm Phase IIa ENTRANCE
study met its primary endpoint of significantly increasing the
response rate in corticosteroid-dependent IBD patients to 88.5%
versus an average placebo response across published benchmark
clinical trials of approximately 20%.
Following completion of a twelve week treatment phase with
vidofludimus, disease remission was maintained in 14 out of 26
patients (53.9%) without intake of any corticosteroids (complete
responders). A further 9 out of 26 patients (34.6%) remained in
remission at the end of the study treatment period at a
corticosteroid dose equal to or below the patients' individual
threshold doses (partial responders) at which they experienced a
documented disease relapse prior to entry into the study. Overall,
vidofludimus significantly increased the number of patients with
response (complete and partial responders = 88.5%) compared to the
pre-defined placebo rate criterion of 20%. Vidofludimus was well
tolerated with no critical safety issues observed. These are
preliminary results prior to database lock and, therefore, subject
to final review.
Information and Explaination of the Issuer to this News:
About the ENTRANCE Study Design
The ENTRANCE study evaluates if disease control in proven
corticosteroid-dependent patients could be transferred from
corticosteroids to vidofludimus as remission maintenance therapy in
IBD patients. The study was conducted at 13 study centres in
Germany, Bulgaria and Romania with about half of the patients being
recruited in Germany. Corticosteroid-dependent male and female
patients with a confirmed diagnosis of Crohn's disease (CD) or
ulcerative colitis (UC) were included into the trial. Vidofludimus
was applied once daily at a 35mg oral dose over a treatment period
of twelve weeks. Simultaneously, corticosteroids were attempted to
be tapered down to zero during the first eight weeks of the trial
period followed by a targeted corticosteroid-free treatment period
of up to four weeks. Out of 34 enrolled patients, 26 were evaluable
for assessment of the primary efficacy parameter which was to
determine the number of patients with therapeutic response to
vidofludimus (complete/partial). Complete response was defined as
corticosteroid-free clinical remission in the last week of the
treatment period. Partial response was defined as being in
remission at any corticosteroid dose equal to or below the
threshold dose of an individual patient, i.e. the steroid dose at
which a patient participating in the ENTRANCE trial already had
experienced a documented disease relapse prior to entering into the
study. Secondary endpoints included the analysis of CDAI/CAI
scores, safety, pharmacokinetic and biomarker data.
4SC will present these preliminary data at the BioEurope
conference in Munich, Germany, on Tuesday, November 16, 2010
(10.15am CET, Room 11, Level 1), while the full data package is
intended to be presented at an upcoming international IBD
conference.
'We are very excited about the ENTRANCE trial results which
confirmed previous activity data of vidofludimus in pre-clinical
IBD models', commented Dr Ulrich Dauer, Chief Executive Officer of
4SC AG. 'With a total response rate of 88.5%, vidofludimus provided
substantial evidence of clinical efficacy in patients with both
Crohn's disease and ulcerative colitis as a novel remission
maintenance therapy.'
'These study results provide a well defined basis for the
positioning and development of vidofludimus as a new oral treatment
option in IBD. We believe these data will also enhance the package
we have already compiled for potential licensees in the
pharmaceutical industry,' added Dr Bernd Hentsch, Chief Development
Officer of 4SC AG.
The lead investigator of the ENTRANCE trial, PD Dr Klaus
Herrlinger, Department of Gastroenterology and Endocrinology at the
Robert-Bosch-Hospital in Stuttgart, Germany, added: 'There is a
high medical need for novel IBD therapies, especially in remission
maintenance therapy, since many of the drugs used today have
limited efficacy or significant side effects. The results from the
ENTRANCE trial are very promising. Vidofludimus could represent a
viable alternative treatment option for IBD patients in the
future.'
For more information about the ENTRANCE trial, please visit
www.clinicaltrials.gov (identifier NCT00820365).
Vidofludimus is also currently being evaluated in the
randomised, double-blind, placebo-controlled Phase IIb COMPONENT
study in patients with rheumatoid arthritis in combination with
methotrexate. Preliminary results are expected to be reported in
the first half of 2011.
Conference Call and WebcastThe senior management team of 4SC
will host a conference call at 4pm CET (10am EST) today to inform
about the preliminary results of the study.
Access to the presentation slides can be obtained at:
http://4sc041110-live.cyber-presentation.de
Dial-in numbers: 0800 10 12 072 (Germany)0800 358 0886 (UK)+1
877 941 6013 (USA)+49 (0) 6103 485 3001 (other countries)
Conference ID: 4377221
Approximately two hours after the live presentation, an audio
replay of the conference will be available on the 'investors'
section of www.4sc.com.
Notes to Editor:
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 (CD) and
ulcerative colitis (UC), which are chronic diseases 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 deregulated
immune response results in inflammatory mediators that attack the
patient's intestinal mucosa and trigger the symptoms.
CD is characterised by an inflammatory affliction of part or the
whole of the digestive tract and is currently incurable.
Approximately 0.9 million people in the seven major industries
suffer from various CD symptoms and mostly contract the disease
between the ages of 20 and 40. CD 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
corticosteroids or immunosuppressants applied either systemically
or locally for the treatment of the symptoms, as well as the
application of biological agents (e.g. TNF-alpha targeting
antibodies).
UC afflicts specifically the large intestine or colon that
includes characteristic ulcers or open sores. UC occurs in
approximately 1.4 million patients in the seven major industries
and is currently treated with anti-inflammatory drugs,
immunosuppressants, and biological therapy targeting specific
components of the immune response. Colectomy (partial or total
removal of the large bowel through surgery) is occasionally
necessary and is considered to be a cure for the disease.
For both, CD and UC, the pro-inflammatory cytokine
interleukin-17 (IL-17) has been demonstrated to play a crucial role
in pathogenesis.
About Vidofludimus
Vidofludimus (4SC-101) is a novel, orally administered small
molecule for the treatment of autoimmune disorders such as
rheumatoid arthritis and inflammatory bowel disease. The
therapeutic efficacy of vidofludimus is based on a dual principle.
Vidofludimus inhibits the expression of interleukin- 17 (IL-17), a
pro-inflammatory cytokine that has a crucial pathogenic role in a
variety of autoimmune diseases. Vidofludimus also inhibits
dihydroorotate dehydrogenase (DHODH), a key enzyme of the
pyrimidine biosynthesis, thereby halting the proliferation of
activated T and B cells which are involved in the pathology of
autoimmune disorders. The combination of two mechanisms of action
provides an innovative therapeutic approach with broad clinical
potential in various autoimmune diseases. Vidofludimus is currently
in a Phase IIb study in rheumatoid arthritis and a Phase IIa study
in inflammatory bowel disease.
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development
company focused on autoimmune and cancer indications. Vidofludimus
(4SC-101), a small molecule, is currently in a Phase IIb study in
rheumatoid arthritis and a Phase IIa exploratory study in
inflammatory bowel disease. The company's lead oncology compound,
resminostat (4SC-201), a pan histone deacetylase (HDAC) inhibitor,
is in Phase II trials in hepatocellular carcinoma and Hodgkin's
lymphoma. Two further oncology compounds, 4SC-203 and 4SC-205, are
in Phase I studies. 4SC develops drug candidates 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.
Founded in 1997, 4SC has 94 employees and has been listed on the
Prime Standard of the Frankfurt Stock Exchange since December
2005.
For further information, please visit www.4sc.com.
Legal NoteThis document may contain projections or estimates
relating to 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.
Language: EnglishCompany: 4SC AGAm Klopferspitz 19a82152
Martinsried DeutschlandPhone: +49 (0)89 7007 63-0Fax: +49 (0)89
7007 63-29E-mail: public@4sc.comInternet: www.4sc.deISIN:
DE0005753818WKN: 575381Listed: Regulierter Markt in Frankfurt
(Prime Standard); Freiverkehr in München, Düsseldorf, Berlin,
Stuttgart
4 SC (TG:VSC)
Historical Stock Chart
From Jan 2025 to Feb 2025
4 SC (TG:VSC)
Historical Stock Chart
From Feb 2024 to Feb 2025
