PARSIPPANY, N.J., and PARIS — October 20, 2026
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Sanofi announced positive Phase 2b long-term extension (LTE) data for duvakitug, an investigational monoclonal antibody targeting tumor necrosis factor-like ligand 1A (TL1A), in patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Presented at United European Gastroenterology (UEG) Week 2026 in Barcelona, the RELIEVE UCCD study showed that clinical and endoscopic improvements were maintained through Week 44 of treatment. Duvakitug targets TL1A, a protein associated with inflammatory pathways and potentially fibrosis in inflammatory bowel disease (IBD). The results showed sustained rates of clinical remission, clinical response and endoscopic improvement in UC, alongside endoscopic response, clinical response and clinical remission in CD. The treatment was generally well tolerated, with a safety profile consistent with the induction study and no new safety concerns identified. Duvakitug remains investigational, and its safety and efficacy have not been evaluated by any regulatory authority.
Duvakitug Maintains Clinical Improvements in Ulcerative Colitis
The RELIEVE UCCD LTE study evaluated maintenance treatment in 130 patients who responded to the initial 14-week induction study, including 72 patients with UC and 58 with CD. Participants were randomized to receive subcutaneous duvakitug at 450 mg or 900 mg every four weeks. At Week 44, the UC cohort demonstrated sustained clinical remission, clinical response and endoscopic improvement. Among patients receiving 450 mg, clinical remission measured by the modified Mayo Score (mMS) was 47% (n=34; 95% confidence interval [CI]: 30–65), clinical response was 82% (95% CI: 61–91), and endoscopic improvement reached 59% (95% CI: 42–76). In the 900 mg group (n=38), clinical remission was 58% (95% CI: 42–73), clinical response was 87% (95% CI: 71–94), and endoscopic improvement was 63% (95% CI: 47–78). Endoscopic improvement was defined by a Mayo Endoscopic Score of 0 or 1, indicating inactive or mild disease activity. The company reported that outcomes were numerically higher with the 900 mg dose, consistent with a potential dose-response relationship. The results are descriptive, with confidence intervals calculated using logistic regression. Walter Reinisch, MD, PhD, co-lead investigator of the LTE study and Director of the Inflammatory Bowel Disease Study Group at the Medical University of Vienna, said the findings highlight the potential for duvakitug to provide durable control of persistent inflammation and symptoms.
Crohn’s Disease Results Show Sustained Endoscopic and Clinical Responses
In the CD cohort, duvakitug maintained endoscopic response and clinical improvements through Week 44. Endoscopic response was defined as a 50% or greater decrease from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD). Among patients receiving 450 mg (n=27), endoscopic response reached 41% (95% CI: 25–62), while clinical response measured by the Crohn’s Disease Activity Index (CDAI) was 81% (95% CI: 63–94) and clinical remission was 81% (95% CI: 65–95). In the 900 mg group (n=31), endoscopic response was 55% (95% CI: 39–75), clinical response was 87% (95% CI: 70–96), and clinical remission was 84% (95% CI: 68–96). As in UC, efficacy outcomes were numerically higher for several endpoints at the higher dose. Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine at Western University and co-lead investigator, said the findings indicate potential for sustained disease control in a condition where some patients do not respond to or stop responding to available therapies. Across both disease groups, the majority of reported adverse events were mild or moderate. Common events in UC included upper respiratory tract infection and nasopharyngitis. In CD, reported events included upper respiratory tract infection, Crohn’s disease, hypertension, nasopharyngitis, anemia and influenza. Adverse-event-related discontinuation rates were low, ranging from 2% to 4% in the UC dose groups and 6% in each CD dose group.
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Biomarker Findings Support Further Investigation of TL1A Inhibition
Additional biomarker analyses from the RELIEVE UCCD induction study, NCT05499130, presented at UEG Week 2026 provided insights into duvakitug’s potential biological effects. In UC, treatment reduced blood markers associated with multiple inflammatory pathways. In CD, reductions were observed in markers connected to the Th17 and Th1 immune pathways. The analyses also showed reductions in markers of neutrophilic inflammation in blood and tissue across both conditions. In patients with CD, duvakitug additionally reduced markers associated with tissue remodeling, providing mechanistic evidence that TL1A inhibition may influence inflammation and potentially fibrosis. The findings complement previously published induction-study clinical results in The Lancet Gastroenterology & Hepatology. Teva and Sanofi are advancing duvakitug through the Phase 3 SUNSCAPE-1 and SUNSCAPE-2 studies in UC and STARSCAPE-1 and STARSCAPE-2 studies in CD. The companies have also initiated the Phase 2 AURALIGHT study in moderate-to-severe hidradenitis suppurativa and are planning a Phase 2 study in fibrostenotic Crohn’s disease. Under their collaboration, Teva and Sanofi share global development costs and share net profits and losses in major markets, with other markets subject to royalty arrangements. Teva will lead commercialization in Europe, Israel and specified countries, while Sanofi will lead in North America, Japan, other parts of Asia and the rest of the world.
Source:::Teva,press release
