Phase 3 Trial Results of Stelara for Crohn’s Disease Indicate Promising Results

Phase 3 Trial Results of Stelara for Crohn’s Disease Indicate Promising Results
Janssen Pharmaceuticals’ drug candidate Stelara (ustekinumab) demonstrated positive therapeutic effects in a recent Phase 3 clinical trial, inducing clinical response and remission in adult patients with moderate to severe Crohn’s disease who had been treated with anti-tumor necrosis factor (TNF)-alpha therapy and were either unresponsive or intolerant to it. The efficacy and safety results from the Second Stelara Phase 3 Induction Study (UNITI-1) were presented at the 11th Congress of the European Crohn's and Colitis Organization. Janssen has submitted applications, currently under review, with the U.S. FDA and the European Medicines Agency seeking approval of Stelara for the treatment of moderate to severe Crohn’s disease. Stelara is a monoclonal antibody antagonist of human interleukin-12 and interleukin-23, molecules that are believed to play a role in the autoimmunity that leads to diseases such as Crohn’s. Janssen launched a comprehensive Phase 3 UNITI clinical development program which included three studies, UNITI-1, UNITI-2 and IM-UNITI. Data from the UNITI-2 study, which evaluated Stelara for the treatment of patients who had failed conventional therapy but were mostly naïve to treatment with anti-TNF-alpha, was presented at the 2015 American College of Gastroenterology Annual Meeting and United European Gastroenterology Week. Data from the IM-UNITI maintenance study will be presented at a future medical congress. The placebo-controlled
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