4SC Presents Final Phase IIa Data On Vidofludimus In Inflammatory Bowel Disease Study At The 6th ECCO IBD Conference

4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, announces the final data from the ENTRANCE Phase IIa trial in inflammatory bowel disease (IBD) with vidofludimus, an oral inhibitor of interleukin-17 (IL-17) release and DHODH, 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%. These were presented last week at the 6th ECCO IBD Conference in Dublin, Ireland.


-- 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


-- 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


Entrance Trial Final Data


The top-line results from the exploratory, open-label, single-arm ENTRANCE Phase IIa study, announced in November 2010, demonstrated a 88.5% total response rate with vidofludimus versus an average placebo response rate of approximately 20% across published benchmark clinical trials, in steroid-dependant IBD patients. 53.9% (14 out of 26) of patients were complete responders, 34.6% (9 out of 26) of patients were partial responders (34.6%), and 11.5% (3 out of 26) of patients were evaluated as non-responders. No variation in response rates across the sub-disease populations of Crohn's disease (85.7%) and ulcerative colitis (91.7%) over the 12 week treatment period was observed.


CDAI/CAI disease score development was in-line with the assignment of patients to the categories complete, partial, and non-responders. All 26 evaluable patients, excluding the three non-responders, reached a relapse-free prednisolone dose which was significantly (p