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

Core Insights - Teva Pharmaceuticals and Sanofi announced positive results from the RELIEVE UCCD long-term extension study of duvakitug, showing durable clinical and endoscopic efficacy over 44 weeks in patients with ulcerative colitis and Crohn's disease [2][6] - The study reinforces the efficacy observed in the previous phase 2b induction study, indicating that duvakitug has the potential to be a best-in-class therapy for inflammatory bowel disease [3][4] Study Details - The RELIEVE UCCD LTE study is a double-blind randomized study evaluating the long-term efficacy, safety, and tolerability of duvakitug in patients who initially responded to the induction phase [2][15] - A total of 130 patients who responded to duvakitug in the induction study entered a 44-week maintenance period, receiving either 450 mg or 900 mg doses every four weeks [4][15] Efficacy Results - At week 44, 58% of patients on the 900 mg dose and 47% on the 450 mg dose achieved clinical remission in ulcerative colitis, while 55% on the 900 mg dose and 41% on the 450 mg dose achieved endoscopic response in Crohn's disease [10] - Consistent benefits were observed across additional efficacy endpoints for both conditions [10] Safety Profile - Both doses of duvakitug were well tolerated, with the most frequent adverse events being upper respiratory tract infection, nasopharyngitis, Crohn's disease, and hypertension, consistent with the phase 2b induction study [5][9] Future Developments - Phase 3 studies for duvakitug are currently underway, with the collaboration between Teva and Sanofi focusing on co-developing and co-commercializing the therapy for ulcerative colitis and Crohn's disease [6][18] - The companies aim to announce additional indications for duvakitug later this year, emphasizing their commitment to providing innovative treatment options [4][6]