4SC Provides Enrolment Update for Phase IIb Rheumatoid Arthritis Study with Vidofludimus (4SC-101)

(PresseBox) ( Planegg-Martinsried, )
4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, today announced that the company anticipates reporting preliminary results from its Phase IIb COMPONENT trial in patients with mild to moderate rheumatoid arthritis with vidofludimus, an oral, diseasemodifying antirheumatic drug (DMARD), during the first half of 2011. Patients for this trial are currently being recruited in Poland, Romania, Bulgaria and the Czech Republic across 29 clinical trial sites.

'We are pleased to announce that to date, we have randomised 153 patients

(63% of a targeted total of 244 patients) for the Phase IIb trial in RA with vidofludimus,' said CEO Ulrich Dauer. 'Based on this current recruitment speed and the recent expansion of the number of participating clinical trial centres we expect to present preliminary results in the first half of 2011.'

Vidofludimus is an oral interleukin-17 (IL-17) and DHODH inhibitor which has broad application options in autoimmune diseases. It is currently being evaluated in the COMPONENT study in combination with methotrexate, compared to methotrexate alone, in rheumatoid arthritis (RA) patients. Vidofludimus is also being evaluated in a Phase IIa trial in inflammatory bowel disease, which will report results in Q4 of 2010.

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 painrelieving medicines, socalled diseasemodifying medicines (DMARDs =disease modifying antirheumatic 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 proinflammatory 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 the COMPONENT study

The COMPONENT trial is a randomised, doubleblind, placebocontrolled, multicentre, 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, oncedaily, 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 www.clinicaltrials.gov.
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