4SC AG / Key word(s): Preliminary Results
04.11.2010 08:05
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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- Vidofludimus generates a response rate of 88.5% for the treatment of
patients with Crohn's disease and ulcerative colitis -
Planegg-Martinsried, Germany - 04 November, 2010 - 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.
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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 Webcast
The 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.
For more information please contact:
4SC AG
Dr. Ulrich Dauer, Chief Executive Officer
Yvonne Alexander, IR & PR
Tel.: +49 (0) 89 70 07 63 0
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
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 Note
This 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.
04.11.2010 08:05 DGAP's Distribution Services include Regulatory Announcements,
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Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Deutschland
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
E-mail: public@4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in München, Düsseldorf, Berlin, Stuttgart
End of Announcement DGAP News-Service
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DGAP-Adhoc: 4SC AG: 4SC's Vidofludimus Meets Primary Endpoint with Excellent Response Rate in IBD Trial
| Quelle: EQS Group AG