4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, today announced positive preliminary results of a Phase IIa study in inflammatory bowel disease (IBD) with its lead autoimmune compound vidofludimus, an oral inhibitor of interleukin-17 (IL-17) release. The exploratory, open-label, single-arm Phase IIa ENTRANCE study met its primary endpoint of significantly increasing the response rate in corticosteroid-dependent IBD patients to 88.5% versus an average placebo response across published benchmark clinical trials of approximately 20%.
Following completion of a twelve week treatment phase with vidofludimus, disease remission was maintained in 14 out of 26 patients (53.9%) without intake of any corticosteroids (complete responders). A further 9 out of 26 patients (34.6%) remained in remission at the end of the study treatment period at a corticosteroid dose equal to or below the patients' individual threshold doses (partial responders) at which they experienced a documented disease relapse prior to entry into the study. Overall, vidofludimus significantly increased the number of patients with response (complete and partial responders = 88.5%) compared to the pre-defined placebo rate criterion of 20%. Vidofludimus was well tolerated with no critical safety issues observed. These are preliminary results prior to database lock and, therefore, subject to final review.
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