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The single-arm, open-label exploratory study will be conducted at four study centres in Germany. 24 patients will be given a 35mg oral dose of 4SC-101 once daily over a treatment period of twelve weeks.
The purpose of the study is to provide evidence of the clinical efficacy in patients with Crohn's disease. The preliminary results are expected by the end of 2009.
'We are pleased that following the successful outcome of the already completed phase IIa study in rheumatoid arthritis, we have now also been able to obtain the authorisation for the clinical evaluation of our drug for Crohn's Disease,' comments Dr Ulrich Dauer, CEO of 4SC AG. 'The results that we have obtained from the previous preclinical studies for this indication are already very promising and we predict that with this extended base of indications, our project will be even more attractive in future to potential licensees in the pharmaceutical industry.'
About Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disorder. The onset of the disease is usually insidious and without a clear cause. It is characterised by an inflammatory affliction of part or of the whole of the digestive tract and is currently incurable. About 4 million people worldwide, especially in the Western industrial countries are suffering from the various symptoms such as abdominal pain, intestinal bleeding, diarrhoea or vomiting. People mostly contract the disease between the ages of 20 and 40.
Crohn's disease leads to a considerable reduction in quality of life but may also involve severe complications requiring immediate surgery. Current therapeutic options for patients with Crohn's disease are largely limited to the use of anti-inflammatory steroids applied either systemically or locally for the treatment of the symptoms.
4SC-101 is a novel small-molecular active agent of the class of disease-modifying drugs known as DMARDs (disease-modifying antirheumatic drugs) for the treatment of auto-immune disorders. The substance acts as a highly selective inhibitor of the biosynthesis of pyrimidines and in this way inhibits the proliferation of rapidly multiplying cells, in particular that of the lymphocytes which are of importance for the immune response.
The drug candidate comes from 4SC's own research pipeline and has already been successfully tested in a phase IIa clinical study on patients with rheumatoid arthritis. In addition, the broad therapeutic potential of 4SC-101 has been further substantiated in several preclinical studies on chronic inflammatory bowel diseases and inflammatory skin conditions.
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