DGAP-News: Press Release 4SC: New data on mode of action reinforce further development of vidofludimus in IBD
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
Press Release 4SC: New data on mode of action reinforce further
development of vidofludimus in IBD
17.02.2012 / 12:20
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Press Release
New data on its unique anti-inflammatory mode of action reinforce further
development of 4SC's lead autoimmune product vidofludimus in IBD
- Two poster presentations at ECCO IBD conference in Barcelona on 17
February
- In preclinical IBD model vidofludimus improves colonic disease by a
unique dual anti-inflammatory mode of action
- Data further encourage current preparation of a clinical Phase IIb
study in IBD
Planegg-Martinsried, 17 February 2012 -
4SC AG (Frankfurt, Prime Standard: VSC), a discovery
and development company of targeted small molecule drugs for autoimmune
diseases and cancer, today presents novel preclinical data of its lead
autoimmune compound vidofludimus demonstrating its unique dual
anti-inflammatory mode of action. Vidofludimus inhibits proliferation of
immune cells and induces apoptosis (cell death) in immune cells as well as
selectively blocks the expression of both pro-inflammatory cytokines
interleukin 17A (IL-17A) and IL-17F. The data will be presented in two
poster presentations at the 7th ECCO IBD conference of the European Crohn's
and Colitis Organisation in Barcelona on 17 February 2012 and will be
available for poster download that day from 12.20 pm (CET) under:
http://www.4sc.de/product-pipeline/publications-posters/vidofludimus. The
presented data further encourage the planned Phase IIb clinical study with
vidofludimus in inflammatory bowel disease (IBD), which the company is
currently preparing in discussions with regulatory authorities and
potential partners. Vidofludimus, an oral inhibitor of IL-17 and DHODH, has
demonstrated strong anti-inflammatory activity and good safety in several
preclinical and clinical studies and met the primary endpoint in a previous
Phase IIa IBD trial.
The data of the first ECCO IBD presentation 'Vidofludimus inhibits IL-17
and improves hapten-induced colitis in young rats by a unique dual mode of
action' show that vidofludimus considerably improves colonic inflammation
in an animal model of induced colitis. The data further suggest that the
anti-inflammatory effect of vidofludimus in this colitis model is caused by
the compound's dual mode of action, namely inhibition of T-cell
proliferation and suppression of pro-inflammatory cytokines including
IL-17. The data of the second presentation 'Vidofludimus induces
p53-mediated apoptosis in activated T-cells and inhibits IL-17A and IL-17F
expression decoupled from lymphocyte proliferation' demonstrate that
vidofludimus strongly inhibits IL-17A and IL-17F production and induces
apoptosis of activated T cells. T cell activation and IL17-A and IL17-F
production are strongly related to autoimmune diseases and chronic
inflammation such as IBD. Thus, these findings not only confirm the dual
mode of action of vidofludimus but also the clinical rationale to further
develop vidofludimus as a novel treatment of autoimmune diseases.
Dr. Ulrich Dauer, CEO of 4SC AG said: 'These novel preclinical data in IBD
models once again demonstrate the broad potential of vidofludimus as a
therapy for autoimmune diseases. They particularly confirm the strong
anti-inflammatory activitythat vidofludimus has already shown in our Phase
IIa ENTRANCE-study in patients with ulcerative colitis and Crohn's disease.
This is a further encouragement for our planned Phase IIb study in IBD
which we are currently preparing in talks with regulatory authorities and
potential partners'.
Ends
Details of the Presentation:
Poster number: P012, Abstract number: A-276
Title: 'Vidofludimus inhibits IL-17 and improves hapten-induced colitis in
young rats by a unique dual mode of action'
Poster session date and time: Friday, February 17, 2012, 12.20-1.15 pm
(CET)
Presenter: Leo R. Fitzpatrick1, Jeffrey S. Small1, R. Doblhofer2, Stefan W.
Henning2, Aldo Ammendola2,
1)Penn State College of Medicine, Hershey PA, USA; 2)4SC AG,
Planegg-Martinsried, Germany
Poster number: P013, Abstract number: A-278
Title: 'Vidofludimus induces p53-mediated apoptosis in activated T cells
and inhibits IL-17A and IL-17F expression decoupled from lymphocyte
proliferation'
Poster session date and time: Friday, February 17, 2012, 12.20-1.15 pm
(CET)
Presenter: Svetlana Hamm1, Stefan W. Henning1, Bernd Hentsch1, Daniel
Vitt1, Manfred Groeppel1, Aldo Ammendola1,
1)4SC AG, Planegg-Martinsried, Germany
About Vidofludimus
Vidofludimus is a novel, orally administered small molecule for the
treatment of autoimmune disorders such as inflammatory bowel disease. The
therapeutic efficacy of vidofludimus is based on a dual principle.
Vidofludimus inhibits the expression of selected pro-inflammatory
cytokines, including interleukin-17 (IL-17A and IL-17F) and IFN-gamma that
play crucial pathogenic roles 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. Vidofludimus has completed a Phase IIa trial in inflammatory
bowel disease meeting the primary endpoint with a response rate of 88.5%
and has completed a Phase IIb study in rheumatoid arthritis showing
substantial anti-inflammatory activity. Preclinical models demonstrate the
broad therapeutic potential of vidofludimus in autoimmune indications
including lupus, psoriasis, multiple sclerosis and transplant rejection.
About 4SC
4SC (ISIN DE0005753818) discovers and develops targeted small-molecule
drugs for the treatment of diseases with a high unmet medical need in
various autoimmune and cancer indications. These drugs are intended to
provide patients with innovative treatment options that are more tolerable
and efficacious than existing therapies, and provide a better quality of
life. The company's balanced pipeline comprises promising products that are
in various stages of clinical development. 4SC's aim is to generate future
growth and enhance its enterprise value by entering into partnerships with
leading pharmaceutical companies. Founded in 1997, 4SC currently has 94
employees and has been listed on the Prime Standard of the Frankfurt Stock
Exchange since December 2005.
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.
For more information please visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Investor Relations&Public Relations
jochen.orlowski(at)4sc.com, Tel.: +49 (0) 89 70 07 63 66
Bettina v. Klitzing-Stückle, Corporate Communications
bettina.von.klitzing(at)4sc.com, Tel.: +49 (0) 89 70 07 63 0
MC Services
Raimund Gabriel
raimund.gabriel(at)mc-services.eu , Tel.: +49 (0) 89 21 02 28 30
Mareike Mohr
mareike.mohr(at)mc-services.eu, Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Crubin(at)troutgroup.com, Tel.: +1 646 378 2947
End of Corporate News
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Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Germany
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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