Teva and Sanofi released positive findings from the RELIEVE UCCD LTE phase 2b long-term extension study evaluating duvakitug. This investigational human monoclonal antibody targets tumor necrosis factor-like ligand 1A (TL1A) and shows durable efficacy in inflammatory bowel disease patients. The study reported both clinical and endoscopic improvements in ulcerative colitis (UC) and Crohn’s disease (CD) over 44 weeks of maintenance treatment. These results suggest long-lasting benefits for patients who responded during the induction phase.
The RELIEVE UCCD LTE trial enrolled patients who had already responded after the 14-week induction period. Participants received 450 mg or 900 mg subcutaneous doses of duvakitug every four weeks. By week 44, 58 % of high-dose UC patients reached clinical remission, compared to 47 % in the lower-dose group. Similarly, 55 % of high-dose CD patients achieved the primary endoscopic response, while 41 % did so in the lower-dose group. These outcomes demonstrate that duvakitug maintains meaningful clinical benefit throughout the long-term study.
Leaders at Teva and Sanofi emphasized that sustaining remission remains a central challenge in UC and CD management. Eric Hughes, MD, PhD, Executive Vice President, Global R&D, and Chief Medical Officer at Teva, stated that these results strengthen confidence in TL1A as a therapeutic target and support continued clinical development of duvakitug.
Inflammatory bowel disease (IBD), including ulcerative colitis and crohn’s disease, causes persistent inflammation in the gastrointestinal tract. The inflammatory bowel disease treatment is growing due to increasing disease prevalence and the rising number of new product launches. Furthermore, long-term data like RELIEVE UCCD LTE provide insights that may improve patient outcomes and treatment planning.
The study reported that duvakitug was generally well tolerated. Common adverse events included upper respiratory tract infections, nasopharyngitis, Crohn’s disease episodes, and hypertension. These events occurred in at least 5 % of participants. Both companies highlighted that safety and tolerability remained consistent with prior studies and revealed no new safety concerns.
Importantly, the RELIEVE UCCD LTE results show that duvakitug’s efficacy extends beyond initial treatment, with benefits maintained for nearly one year. This durability is critical because UC and CD are chronic, relapsing diseases that often require lifelong management. Prolonged inflammation can lead to complications such as fibrosis or intestinal damage. This makes sustained remission an essential goal for patients and clinicians alike.
Duvakitug selectively inhibits TL1A-DR3 signaling, which plays a key role in amplifying inflammatory responses and promoting gut fibrosis. By targeting TL1A preferentially over decoy receptor interactions, the therapy reduces inflammation and may improve disease progression compared to current treatments.
These maintenance data build on findings from the initial RELIEVE UCCD induction phase, where duvakitug showed significantly higher response rates than placebo. High-dose UC patients achieved improved clinical remission, and CD patients displayed enhanced endoscopic response. Combining induction and maintenance results supports advancing duvakitug into phase 3 trials, which will further evaluate efficacy, safety, and long-term benefits.
Teva and Sanofi are co-developing and co-commercializing duvakitug globally. Sanofi leads the phase 3 clinical program, while Teva manages commercialization in Europe, Israel, and selected other regions. This partnership highlights duvakitug’s strategic importance and demonstrates a shared commitment to addressing unmet needs in IBD.
As IBD incidence rises worldwide, RELIEVE UCCD LTE data offer hope for durable treatments beyond short-term symptom relief. Achieving lasting efficacy over time represents an important step forward in managing these complex, chronic diseases. Phase 3 trials underway will determine how these benefits translate into clinical practice.
Detailed results from RELIEVE UCCD LTE are expected at upcoming medical meetings. These presentations will provide additional insights into patient subgroups, long-term safety, and potential real-world impact. Patients, clinicians, and investors will closely follow these findings as duvakitug progresses toward regulatory review and potential availability.
