4SC AG — Regulatory Filings 2012

Feb 17, 2012

News Details

Corporate | 17 February 2012 12:20

Press Release 4SC: New data on mode of action reinforce further development of vidofludimus in IBD

4SC AG / Key word(s): Miscellaneous

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 7 th 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 activity that 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. Fitzpatrick 1 , Jeffrey S. Small 1 , R. Doblhofer 2 , Stefan W. Henning 2 , Aldo Ammendola 2 ,

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 Hamm 1 , Stefan W. Henning 1 , Bernd Hentsch 1 , Daniel Vitt 1 , Manfred Groeppel 1 , Aldo Ammendola 1 ,

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@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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