4SC AG, 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.
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