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4SC Announces Initial Results From its Phase IIa Clinical Study With SC12267.

PLANEGG-MARTINSRIED, Germany, November 29 /PRNewswire/ -- German drug discovery and development company 4SC AG (Frankfurt, Prime Standard: VSC), based in Martinsried near Munich, today announced the first results of their Phase IIa clinical study with SC12267 for the treatment of rheumatoid arthritis.

In the randomized, double-blind, placebo-controlled study, two groups of patients were treated over a period of 12 weeks with a daily oral administration of two different doses of SC12267 (20 mg and 35 mg). Over the same period of time, another group of patients received a placebo. The last of the participating patients was released from the study at the beginning of October. The aim of the study was to prove the efficacy, safety and pharmacokinetics of the drug candidate.

The available study results demonstrate good tolerability and safety for SC12267. Efficacy was shown depending on selected clinical endpoints and previous medication of the patients.

To prove efficacy, the so-called DAS28 score for measuring disease activity and the international established ACR response criteria for assessing treatment success were defined as clinical endpoints.

In accordance with ACR20-responses (a measure for the reduction of RA-symptoms of at least 20%) the results confirmed dose-dependent trends in efficacy. Results showed that an ACR20 response was attained in about 47% of patients in the 35-mg group compared to approximately 33% of patients in the placebo group.

Evaluating the DAS28 score (a tool for the judgement of the disease activity of RA patients on the basis of 28 defined joints) a reduction was observed in all three treatment groups after 12 weeks of treatment, but due to a high placebo response rate the differences in the 20 mg and 35 mg groups compared to placebo were not conclusive.

Very pronounced was data of patients who had received treatment with other DMARDs (disease modifying antirheumatic drugs) prior to the trial, and were now given a 35 mg dose of SC12267. A clear, positive trend in efficacy could be achieved for all parameters compared to the placebo group.

 Subgroup analysis of DMARD pre-treated patients:

 ACR20 ACR50 ACR70 DAS28
 (CRP) (1)
 Placebo 13% 6.7% 0% -0.69
 20 mg 25% 0% 0% -0.94
 35 mg 50% 20% 20% -1.50

(1) Change in DAS during treatment (mean value), the less the DAS28 value, the more positive is the clinical effect.

"The clear efficacy in the relevant patient groups is of particular importance for this new drug candidate," commented Prof. Dr. Bernhard Manger of the Institute for Rheumatology and Clinical Immunology at the Medical Clinic III, University Erlangen-Nurnberg and principal investigator of the study. "This safety and efficacy data opens up new options for the basic treatment of rheumatoid arthritis."

The final study report is expected within the next weeks after completion of additional evaluations. 4SC AG will use the available data for further talks with potential partners in the pharmaceutical industry.

"It isn't just the potential of SC12267 in the treatment of rheumatoid arthritis, as confirmed in this study, which may convince our potential licensing partners," said Dr. Ulrich Dauer, CEO of 4SC AG. "We are also confident that the opportunities arising from the development of this drug candidate for the treatment of other autoimmune diseases such as multiple sclerosis or chronic inflammatory bowel diseases will boost the potential of this project."

Rheumatoid Arthritis

Rheumatoid Arthritis is a chronic inflammatory joint disease that afflicts 0.5 - 1% of the population; women are three times more likely to get arthritis than men are. 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. Besides pain-relieving medicines, so-called disease-modifying medicines (DMARDs = disease modifying anti-rheumatic drugs) can be used in treatment. These drugs are used to induce a healing process.

They differ from other groups of drugs used in the treatment of rheumatoid diseases, since only 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 damage to joints and provide support for the repair of changes that have already occurred.


SC12267 is a new type of small molecular active agent from the class of DMARDs used for treatment of autoimmune diseases such as rheumatoid arthritis or multiple sclerosis. The substance works as a highly selective inhibitor in the biosynthesis of pyrimidine, which inhibits the proliferation of fast proliferating cells, in particular the important lymphocytes used for immune response.

The broad therapeutic potential of SC12267 was also further underpinned in several preclinical studies for chronically inflammatory intestinal diseases and inflammatory skin diseases. This data, together with the experiences from the clinical phase IIa study form the basis for swift clinical development in other indications.

About 4SC AG:

4SC AG (ISIN DE0005753818) has been listed in the Prime Standard of Frankfurt Stock Exchange since 15 December 2005. Founded in 1997 and now with a staff of 63, the company develops novel drug candidates for inflammatory diseases and cancer using a cheminformatics based technology platform. Traditional high throughput screening of therapeutic agents has been transferred from the lab to the computer. Thus, the company offers substantial cost and time advantages as well as increased success rates in drug development. 4SC AG uses its patented technology platform to create a sustainable product pipeline for active agents that are developed in early clinical phases ("proof of concept") and subsequently result in upfront and milestone payments as well as participation in sales generated by out-licensed products to the pharmaceutical industry. There are currently six projects in the pipeline. The first project on the treatment of rheumatoid arthritis is currently undergoing clinical phase IIa. Four other product candidates are in preclinical development and another project is in the research stage. Furthermore, the company has its technology platform in co-operation projects with biotech and pharma companies and is already generating initial revenues.

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:
 Bettina von Klitzing
 Manager Investor Relations and Public Relations
 Tel.: +49(0)-89-70-07-63-0

For more information please contact: Bettina von Klitzing, Manager Investor Relations and Public Relations, 4SC AG, Tel.: +49(0)-89-70-07-63-0,
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Publication:PR Newswire Europe
Article Type:Clinical report
Date:Nov 29, 2007
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