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4SC AG. (12/20/10). "Press Release: 4SC Completes Enrolment of the Phase IIb COMPONENT Trial with Vidofludimus in Rheumatoid Arthritis". Planegg-Martinsried.

Region Region Poland
Organisation Organisation 4SC AG (FSE: VSC)
  Group 4SC (Group)
Product Product vidofludimus (4SC-101)
Person Person Dauer, Ulrich (Probiodrug 201805– CEO before Omeicos + Activaero + 4SC + Tripos)

4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.

COMPONENT is a randomised, double-blind, placebo-controlled, multi-centre, international Phase IIb study evaluating the efficacy of vidofludimus in RA with methotrexate, compared to methotrexate alone. A total of 244 RA patients were recruited for this trial across 29 clinical trial sites in Poland, Romania, Bulgaria and the Czech Republic.

"Completion of COMPONENT enrolment is a critical milestone in the development of vidofludimus and ensures we are on track to see the Phase IIb outcome in RA for this novel, oral inhibitor of IL-17 release," said Ulrich Dauer, CEO of 4SC AG. "Through the concentrated efforts of physicians and patients we have jointly been able to explore the efficacy of vidofludimus in a large population of RA patients on MTX background and look forward to presenting the data in 2011."

The recently announced exploratory Phase IIa ENTRANCE trial of vidofludimus in inflammatory bowel disease met the primary endpoint and achieved a response rate of 88% in Crohn's disease and ulcerative colitis patients.

- Ends -

About the COMPONENT Study

The COMPONENT trial is a randomised, double-blind, placebo-controlled, multi-centre, international Phase IIb study, which is 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 will include 244 patients in two study arms. The first arm receives 35mg of vidofludimus, once-daily, plus methotrexate, the second receives placebo plus methotrexate. The study duration is 13 weeks and eligible patients must have 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 trial can be found on

About Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is a chronic inflammatory joint disease that afflicts 0.5 - 1% of the World's population. Women are three times more likely to get arthritis than men. In the late stage of the disease, irreversible damage to joint cartilage and bones occurs. Causes of this disease are genetic as well as autoimmune factors. Aside from pain-relieving medicines, so-called disease-modifying medicines (DMARDs = disease modifying anti-rheumatic drugs) can be used in treatment. DMARDs can be synthetic small molecules or biologicals (for example antibodies). They differ from other groups of drugs used in the treatment of rheumatoid diseases, because they are able to stop or reduce damage caused from chronic inflammation to the joint cartilage or bone. In the most favourable cases, some DMARDs can also induce repair of joints and provide support for the repair of changes that have already occurred.

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 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 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 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.

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 contact:

Yvonne Alexander
Investor & Public Relations
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

Record changed: 2017-04-02


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