Date: 2011-02-28
Type of information:
phase: 2a
Announcement: results
Company: 4SC (Germany)
Product: Vidofludimus (4SC-101)
Action mechanism: inhibitor of interleukin-17 (IL-17) release and DHODH (dihydroorotate dehydrogenase)
Disease: inflammatory bowel disease
Therapeutic area: Inflammatory diseases
Country:
Trial
details: 4SC has announced the final data from the ENTRANCE Phase IIa trial in inflammatory bowel disease (IBD) with vidofludimus, including the secondary endpoints comprising the analysis of CDAI (Crohn's disease, CD) and CAI (ulcerative colitis, UC) disease scores, change of prednisolone intake and threshold doses, safety, pharmacokinetics and biomarkers. The data support the previously reported top-line primary endpoint result, which was achieved with a total response rate of 88.5%.
Primary objective of the ENTRANCE study in 26 CD and UC patients was to assess vidofludimus' remission maintenance potential in steroid-dependant IBD patients upon steroid weaning. This primary endpoint was met with an 88.5% total response rate (complete and partial responders), supported by secondary endpoint results demonstrating a clear clinical benefit for treated IBD patients. Required relapse-free prednisolone doses at the end of vidofludimus therapy were significantly lower than average doses needed prior to study entry. Average prednisolone consumption dramatically dropped over the course of the treatment period. Prednisolone threshold doses of partial responders at the end of the treatment were significantly reduced compared to documented threshold doses prior to study entry. Vidofludimus was safe and well tolerated by all patients
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