Teva and Sanofi's duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn's disease

Core Viewpoint - Teva Pharmaceuticals and Sanofi announced positive results from the RELIEVE UCCD long-term extension study of duvakitug, showing durable clinical and endoscopic efficacy in patients with ulcerative colitis and Crohn's disease over a 44-week period [2][4][5]. Group 1: Study Results - The RELIEVE UCCD LTE study demonstrated that duvakitug maintained durable efficacy for an additional 44 weeks in patients who initially responded to the induction phase [8]. - In the study, 58% of patients treated with 900 mg and 47% with 450 mg of duvakitug achieved clinical remission in ulcerative colitis, while 55% with 900 mg and 41% with 450 mg achieved endoscopic response in Crohn's disease [9]. - The study enrolled 130 patients who received either 450 mg or 900 mg of duvakitug every four weeks for up to 58 weeks, with both doses being well tolerated [4][8]. Group 2: Safety and Tolerability - The most frequently observed adverse events (≥5% of all patients) included upper respiratory tract infection, nasopharyngitis, Crohn's disease, and hypertension, consistent with the phase 2b induction study [4][8]. - Safety data from the long-term extension study were consistent with the findings from the induction study, reinforcing the tolerability of duvakitug [8]. Group 3: Future Development - Teva and Sanofi are committed to advancing duvakitug, with ongoing phase 3 studies aimed at providing new treatment options for patients with inflammatory bowel disease [5][17]. - The collaboration between Teva and Sanofi involves co-developing and co-commercializing duvakitug, sharing development costs and profits in major markets [17].