DGAP-News: 4SC Presents Final Phase IIa Data on Vidofludimus in Inflammatory Bowel Disease Study at the 6th ECCO IBD Conference
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Research Update
4SC Presents Final Phase IIa Data on Vidofludimus in Inflammatory
Bowel Disease Study at the 6th ECCO IBD Conference
28.02.2011 / 07:30
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Planegg-Martinsried, Germany - 28 February, 2011 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, announces the final data from the
ENTRANCE Phase IIa trial in inflammatory bowel disease (IBD) with
vidofludimus, an oral inhibitor of interleukin-17 (IL-17) release and
DHODH, including the secondary endpoints comprising the analysis of CDAI
(Crohn's disease, CD) and CAI (ulcerative colitis, UC) disease scores,
change of prednisolone intake and threshold doses, safety, pharmacokinetics
and biomarkers. The data support the previously reported top-line primary
endpoint result, which was achieved with a total response rate of 88.5%.
These were presented last week at the 6th ECCO IBD Conference in Dublin,
Ireland.
* Primary objective of the ENTRANCE study in 26 CD and UC patients was to
assess vidofludimus' remission maintenance potential in steroid-dependant
IBD patients upon steroid weaning
* Primary endpoint was met with an 88.5% total response rate (complete and
partial responders), supported by secondary endpoint results demonstrating
a clear clinical benefit for treated IBD patients
* Required relapse-free prednisolone doses at the end of vidofludimus
therapy were significantly lower than average doses needed prior to study
entry
* Average prednisolone consumption dramatically dropped over the course of
the treatment period
* Prednisolone threshold doses of partial responders at the end of the
treatment were significantly reduced compared to documented threshold doses
prior to study entry
* Vidofludimus was safe and well tolerated by all patients
ENTRANCE TRIAL FINAL DATA
The top-line results from the exploratory, open-label, single-arm ENTRANCE
Phase IIa study, announced in November 2010, demonstrated a 88.5% total
response rate with vidofludimus versus an average placebo response rate of
approximately 20% across published benchmark clinical trials, in
steroid-dependant IBD patients. 53.9% (14 out of 26) of patients were
complete responders, 34.6% (9 out of 26) of patients were partial
responders (34.6%), and 11.5% (3 out of 26) of patients were evaluated as
non-responders. No variation in response rates across the sub-disease
populations of Crohn's disease (85.7%) and ulcerative colitis (91.7%) over
the 12 week treatment period was observed.
CDAI/CAI disease score development was in-line with the assignment of
patients to the categories complete, partial, and non-responders. All 26
evaluable patients, excluding the three non-responders, reached a
relapse-free prednisolone dose which was significantly (p<0.001) lower
than their individual threshold doses at which they experienced relapses
prior to entering into the study. In addition, the decrease of prednisolone
intake over the 12 week treatment period indicates a strong steroid-sparing
effect from vidofludimus. Mean prednisolone consumption was significantly
(p<0.001) lowered from 26.5 mg/day (±8.0) at treatment start to 1.0
mg/day (±2.7) at week 12. In addition to complete responders who by
definition were in steroid-free remission at the end of the study, also
partial responders experienced a significant clinical benefit. The mean
prednisolone threshold dose of partial responders significantly
(p<0.001) dropped from 12.5 mg/day (±3.1) before study start to 1.4
mg/day (±2.5) at the end of the study. As expected, due to the inclusion
of patients in remission and on concomitant treatment with prednisolone,
biomarker data (IL-17, C-reactive protein CRP, erythrocyte sedimentation
rate ESR, and calprotectin) revealed poor or no correlation with patients'
disease activity. However, these biomarkers are expected to be valuable
parameters to characterize the disease status and to potentially stratify
patient populations in future IBD trials with vidofludimus.
Vidofludimus was safe and well tolerated by all patients. No clinically
relevant changes of pulse rate, blood pressure, electrocardiography, body
temperature, hematology and biochemistry were recorded. A total of 75
adverse events (AEs) were reported (53 mild, 18 moderate, 4 severe) of
which 19 AEs were judged by investigators as 'possibly' or 'probably'
drug-related. These included isolated cases of nasopharyngitis, abdominal
pain, fatigue, insomnia, glucosuria, leucocyturia, microhematuria,
musculoskeletal pain, myalgia, tachycardia, and dyspepsia. No drug-related
serious adverse events (SAEs) were reported.
Dr Bernd Hentsch, Chief Development Officer of 4SC, commented, 'The
ENTRANCE study has produced encouraging data with vidofludimus in
inflammatory bowel disease, an indication that is underserved for patients
and is lacking effective and safe drugs especially in long-term remission
maintenance therapy. These data provide early evidence that our oral
therapy vidofludimus could provide such an alternative and we look forward
to assessing the potential of this compound in further IBD trials.'
Copies of the poster are available on the 4SC website under:
http://www.4sc.de/product-pipeline/publications-posters.
- Ends -
For more information please contact:
4SC AG
Yvonne Alexander, IR&PR
Tel.: +49 (0) 89 70 07 63 66
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 30
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947?Notes to Editor:
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.
In addition to the Phase II study in inflammatory bowel disease,
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 Q2 2011.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a group of inflammatory conditions of
the gastrointestinal tract. The main forms are Crohn's disease (CD) and
ulcerative colitis (UC). These chronic diseases are constituted by
acute-disease flare ups which include abdominal pain, rectal bleeding,
diarrhoea, weight loss, fatigue and other extra-intestinal symptoms and
symptom-free phases. It is assumed that a deregulated immune response
results in inflammatory mediators that attack the patient's intestinal
mucosa and trigger the symptoms. For both, CD and UC, the pro-inflammatory
cytokine interleukin-17 (IL-17) has been demonstrated to play a crucialrole in pathogenesis.
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 agents 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.
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 Phase II development in rheumatoid
arthritis and inflammatory bowel disease (IBD), for which positive results
from a Phase IIa study were recently reported. The company's lead oncology
compound, resminostat (4SC-201), a pan-histone deacetylase (HDAC)
inhibitor, is in Phase II trials in hepatocellular carcinoma, Hodgkin's
lymphoma and KRAS-mutant colorectal cancer. 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
End of Corporate News
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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(at)4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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113615 28.02.2011
Datum: 28.02.2011 - 07:30 Uhr
Sprache: Deutsch
News-ID 33309
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