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4SC AG Starts Phase I Study of Product Candidate for Treatment of Rheumatoid Arthritis

Posted on: Wednesday, 10 December 2003, 06:00 CST

MARTINSRIED, Germany, Dec. 10 /PRNewswire/ -- 4SC, a drug discovery and development company today announced the start of clinical phase I trials of its first small molecule product candidate SC12267 for the treatment of rheumatoid arthritis. In this study the compound will be examined with 56 healthy volunteers divided into seven groups with eight participants each regarding the safety, tolerability, and pharmacokinetics of the agent under increasing dosage.

4SC started development of its own molecule using its cheminformatics-based technology platform in mid-2001. In a final step, preclinical studies confirmed the efficacy and safety of the product candidate, convincing both the ethics committee and the study participants.

"The clinical test will be carried out in cooperation with the research institute 3C in Hennigsdorf near Berlin, an institute with a high level of competence in the area of clinical studies, especially in phase I," explained Dr. Charlotte Herrlinger.

As Vice-President Medicine at 4SC, Dr. Herrlinger has been responsible for the further development of product candidates in the clinical phases since the beginning of this year.

"The start of clinical trials with this product candidate is an important milestone in our company's development," added Dr. Ulrich Dauer, CEO of 4SC. "With them, we are once again demonstrating the efficiency of our technology platform and the competence of our team in all aspects of early drug discovery up to the clinical development of novel small molecule drug candidates."

Rheumatoid arthritis

Rheumatoid arthritis is a chronic inflammatory arthropathy from which 1% of the population suffers; women are three times more likely to have the disease. In its latter stage, irreversible harm to the articular cartilage and bones occurs. The causes of the disease are both genetic and auto-immunity factors. Up to now, rheumatoid arthritis remains incurable. Only the symptoms are treatable, for example, through the use of DMARD's (disease modifying antirheumatic agents).

SC12267

SC12267 is a novel small molecule DMARD for the treatment of immunologic diseases, such as rheumatoid arthritis. It acts as a highly selective inhibitor of pyrimidine synthesis. In this way, an increase in strongly proliferating cells -- such as T cells during immune response -- is inhibited. It could be demonstrated during preclinical investigations that SC12267 showed promising pharmacokinetic attributes -- such as good oral bioavailability with only slight toxic potential.

About 4SC:

4SC is a drug discovery and development company that uses its cheminformatics-based technological platform for the discovery and development of new drug candidates. By combining the disciplines of chemistry and biology with the proprietary virtual High Throughput Screening technology, 4SCan(R), the time and cost of advancing a drug candidate to the development phase can be significantly reduced. The company's therapeutic focus centres on infectious and hyperproliferative diseases. The first project for treatment of rheumatoid arthritis is currently being tested in clinical phase I. Four additional research projects in the areas of the indication of cancer diseases, transplantation, cystic fibrosis, and ophthalmology are currently undergoing preclinical evaluation and pharmacokinetics studies. 4SC, which was founded in 1997, today employs 60 people and is based in Martinsried, near Munich, Germany. Further information about the company is available at http://www.4sc.com/.

4SC AG

CONTACT: Bettina von Klitzing of 4SC AG, +49-89-700-763-0, orBettina.von.Klitzing@4sc.com

Web site: http://www.4sc.com/

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