DGAP-Adhoc: 4SC Announces Topline Results of Phase IIb Trial of Vidofludimus in Rheumatoid Arthritis

4SC AG  / Key word(s): Research Update

08.06.2011 07:34

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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Planegg-Martinsried, Germany - June 8, 2011 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today announced topline
results from its randomised, double-blind, placebo-controlled Phase IIb
clinical trial COMPONENT in RA. This compared vidofludimus, an oral
inhibitor of DHODH and pro-inflammatory cytokines (including IL-17A and
IL-17F as well as INF-gamma), in rheumatoid arthritis patients on
methotrexate background therapy versus methotrexate monotherapy over a
treatment period of 13 weeks.

ACR20 response improvement of the 35 mg vidofludimus group compared to
placebo was statistically significant (p<0.05) at week 2 (16.7% vs.
6.9%) and week 8 (46.7% vs. 31.9%), however, vidofludimus missed the
primary endpoint of significantly improving ACR20 response at week 13
(50.0% vs. 44.8%). Time to ACR20 response was significantly (p<0.05)
shorter in the vidofludimus group compared to placebo (median 56 days vs.
92 days). The patient group treated with vidofludimus also reported higher
ACR50 (25.8% vs. 17.2%) and ACR70 (12.5% vs. 6%) response rates compared to
placebo at week 13.

Overall, vidofludimus was safe and well tolerated. No obvious differences
in the adverse event rate between the vidofludimus and placebo group were
observed. In particular, there were no relevant increases of diarrhea,
neutropenia, anemia, hypertension, cholesterol or liver enzyme levels. Only
one serious adverse event was reported in the vidofludimus group which was
judged as not related to vidofludimus. No deaths occurred. These safety
results were consistent with previous Phase IIa trial results in RA and
inflammatory bowel disease patients

4SC will continue to analyse the current data set and the new data that
will become available in the weeks ahead. The Company will use this data
and data from previous trials to continue its discussions with potential
partners. Meanwhile 4SC's future development of vidofludimus will be
focused on inflammatory bowel disease (IBD) and, potentially, other
autoimmune indications such as lupus and psoriasis.

- End of ad hoc announcement -

For more information please contact: 

4SC AG
Dr Ulrich Dauer, Chief Executive Officer
Tel.: +49 (0) 89 70 07 63 0
Yvonne Alexander, IR & PR 
Tel.: +49 (0) 89 70 07 63 66

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 Vidofludimus
Vidofludimus 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 selected
pro-inflammatory cytokines, including interleukin-17 (IL-17A and IL-17F)
and INF-gamma that have 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 positive
Phase IIa trial in inflammatory bowel disease.  In addition, various
preclinical models demonstrate the application options of vidofludimus in
further autoimmune indications such as lupus, psoriasis, multiple sclerosis
and transplant rejection.

About the COMPONENT study
The COMPONENT study is a randomised, double-blind, placebo-controlled,
multi-centre, international Phase IIb study evaluating the efficacy of
vidofludimus with methotrexate, compared to methotrexate alone, in
rheumatoid arthritis (RA) patients. The primary endpoint of this study is
the estimation of ACR20, secondary endpoints are ACR50, ACR70, DAS28,
safety parameters and pharmacokinetics. The trial enrolled 241 patients in
two study arms across 28 sites in Poland, Romania, Bulgaria and Czech
Republic. In the first study arm patients received 35mg of vidofludimus
given orally once-daily plus methotrexate, in the second study arm patients
received placebo plus methotrexate. The study duration was 13 weeks and
eligible patients must have had active RA, have received weekly doses of
MTX (10 25 mg/week) for a minimum of 3 months prior to Day 1 dosing, and
have received a stable MTX dose for at least 6 weeks prior to Day 1 dosing.

More information about the COMPONENT study can be found on
www.clinicaltrials.gov (Identifier NCT01010581).

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.

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.


08.06.2011 DGAP's Distribution Services include Regulatory Announcements, 
Financial/Corporate News and Press Releases. 
Media archive at www.dgap-medientreff.de and www.dgap.de

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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 Berlin, Düsseldorf, München, Stuttgart
 
End of Announcement                             DGAP News-Service
 
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