Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA ® (guselkumab) in Adults With Moderately to Severely Active Crohn's Disease

SPRING HOUSE, PENNSYLVANIA, November 17, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced topline results from the Phase 2 GALAXI 1 clinical trial which showed rates of clinical remission (Crohn’s Disease Activity Index [CDAI]<150) previously reported at week 12 increased at week 48 among adults with moderately to severely active Crohn’s disease (CD) treated with TREMFYA® (guselkumab).1 At week 48, 65 percent of patients receiving TREMFYA achieved clinical remission. TREMFYA is under investigation and not currently approved for the treatment of CD in the U.S.2Janssen previously announced week 12 interim analyses from the 48-week, double-blind, placebo-controlled, multicenter Phase 2 dose-ranging GALAXI 1 study. The primary endpoint of the Phase 2 study is change from baseline in CDAI scores at week 12 in patients treated with TREMFYA compared to placebo.3 Overall, all TREMFYA treatment groups during the 48-week treatment period in GALAXI 1 had comparable safety data, consistent with the known safety profile for TREMFYA.“We look forward to sharing the comprehensive GALAXI 1 48-week results at an upcoming scientific medical meeting while we continue to progress and enroll patients in the pivotal Phase 3 GALAXI 2 and 3 studies,” said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC.The 48-week GALAXI 1 results mark the first long-term data evaluating TREMFYA in moder...
Source: Johnson and Johnson - Category: Pharmaceuticals Source Type: news