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news.4SC AG has completed patient recruitment in a randomized, double-blind, placebo-controlled, multi-centre, international Component Phase IIb study evaluating Vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients.
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Component is investigating the efficacy of vidofludimus in RA with methotrexate, compared to methotrexate alone.
In the rial, a total of 244 RA patients were recruited for this trial across 29 clinical trial sites in Poland, Romania, Bulgaria and the Czech Republic.
In an 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.
4SC CEO Ulrich Dauer said that the completion of Component enrolment is a critical milestone in the development of Vidofludimus and ensures they are on track to see the Phase IIb outcome in RA for this novel, oral inhibitor of IL-17 release.
"’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," Dauer said.