Teva Pharmaceuticals and Sanofi today announced that the Phase 2b RELIEVE UCCD study of duvakitug (TEV’574/SAR447189), an anti-TL1A monoclonal antibody, met its primary endpoints for the treatment of moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). The study, which evaluated the efficacy and safety of duvakitug, showed promising results for patients suffering from inflammatory bowel disease (IBD).
In the RELIEVE UCCD study, duvakitug demonstrated significant improvements compared to placebo. For UC patients, 36.2% of those on the low-dose and 47.8% of those on the high-dose of duvakitug achieved clinical remission by week 14, compared to 20.45% on placebo. The placebo-adjusted remission rates were 15.7% for the low dose and 27.4% for the high dose (p=0.050 and 0.003, respectively). For CD patients, 26.1% of those on the low-dose and 47.8% on the high-dose of duvakitug achieved endoscopic response at week 14, compared to just 13.0% on placebo. The placebo-adjusted endoscopic response rates were 13.0% for the low dose and 34.8% for the high dose (p=0.058 and <0.001, respectively). These results were consistent across all subgroups of patients.
This study is the first randomized, placebo-controlled trial to assess an anti-TL1A monoclonal antibody for CD, marking a significant milestone in IBD treatment. Full results are expected to be presented at a scientific forum in 2025.
Duvakitug was generally well tolerated in both UC and CD patients, with no new safety signals identified. Treatment-emergent adverse events (AEs) were similar between the duvakitug and placebo groups, affecting 50% of patients in both groups. All AEs were mild, with none exceeding 5% in frequency.
Eric Hughes, MD, PhD, Head of Global R&D and Chief Medical Officer at Teva, expressed excitement over the results, stating, “The results from the RELIEVE UCCD study have exceeded our expectations. Duvakitug has the potential to significantly improve the quality of life for people living with IBD. We look forward to working with Sanofi in the next phase of development and thank the investigators and patients for their contributions.”
Houman Ashrafian, MD, PhD, Executive Vice President and Head of R&D at Sanofi, highlighted the significance of the results, saying, “These unprecedented results suggest that duvakitug could become a key treatment for UC and CD. If this efficacy is sustained in Phase 3, we will have a differentiated option for patients in urgent need of new treatments.”
Duvakitug is still under clinical investigation, and its safety and efficacy have not yet been evaluated by regulatory authorities.
