Sanofi (EPA: SAN, NASDAQ: SNY) and Teva Pharmaceutical Industries Ltd (NYSE: TEVA) presented Phase IIb data for duvakitug, their experimental monoclonal antibody targeting TL1A, at the 20th European Crohn’s and Colitis Organisation (ECCO) Congress. The RELIEVE UCCD study evaluated the drug in moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD), showing promising efficacy in both cohorts.
Study Highlights
Duvakitug, co-developed by Sanofi and Teva, demonstrated significant clinical remission and endoscopic response rates in patients with UC and CD. In the UC cohort, 36% (450 mg dose) and 48% (900 mg dose) of patients achieved clinical remission at Week 14, compared to 20% with placebo. Placebo-adjusted rates were 16% (450 mg) and 27% (900 mg), with statistical significance (p=0.050 and p=0.003). In the CD cohort, 26% (450 mg) and 48% (900 mg) achieved endoscopic response, vs. 13% with placebo. Placebo-adjusted rates were 13% (450 mg) and 35% (900 mg), with significance (p=0.058 and p<0.001).
Partnership Structure
Sanofi leads Phase III development and will commercialize duvakitug in North America, Japan, and Asia, while Teva will handle Europe, Israel, and other markets. The companies share global development costs and profits equally.
Therapeutic Implications
Duvakitug’s efficacy in both advanced therapy–experienced and naïve subgroups underscores its potential as a broad-spectrum treatment for inflammatory bowel diseases (IBDs). The results position the drug as a contender in the competitive IBD market, with Phase III trials expected to further validate its profile.-Fineline Info & Tech
Leave a Reply