Ozanimod Lessens Inflammation in Crohn’s, Early Phase 2 Trial Data Show

Ozanimod Lessens Inflammation in Crohn’s, Early Phase 2 Trial Data Show
Daily treatment with 1 mg of ozanimod reduced gut inflammation in patients with moderately to severely active Crohn’s disease, early data from the phase 2 STEPSTONE study show. B.G. Feagan of Western University, London, Ontario, Canada, presented the results in a poster titled “Early histological improvement demonstrated with oral ozanimod in patients with moderately to severely active Crohn’s disease in the STEPSTONE trial” at the 14thCongress of European Crohn's and Colitis Organisation (ECCO), March 6-9 in Copenhagen, Denmark. Ozanimod is an investigational therapy being developed by Celgene that works as an “immunomodulator.” The therapy reduces the number of activated lymphocytes (a type of immune cells) circulating in the gastrointestinal tract by targeting two receptor proteins — the sphingosine-1-phosphate (S1P)-1 and -5. The open-label STEPSTONE study (NCT02531113) is testing ozanimod in patients with moderately to severely active Crohn’s disease. Patients were first enrolled in an induction period of 12 weeks, where they all received 1.0 mg of ozanimod daily. Patients who complete the induction period can enter the 100-week extension period, where they will continue to receive study medication. The trial enrolled 69 patients (mean age 38). Researchers presented data from a post hoc analysis with data from the 12-week treatment period where they used the Robarts Histopathology Index (RHI) to assess the treatment’s efficacy. RHI is a validated index scoring system that evaluates disease activity by assessing the characteristics of the gut tissue, namely inflammation state, including the number of immune cells that infiltrate the gut. The total score ranges from 0 (no disease activity) to 33 (severe disease activity). The a
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