From GlobeNewswire: 2025-02-22 02:20:00

New detailed data from the RELIEVE UCCD study show the efficacy and safety of duvakitug in treating ulcerative colitis and Crohn’s disease. The study found that the drug was effective in achieving clinical remission and endoscopic response across various subgroups. These positive results will pave the way for a Phase 3 program expected to begin in the second half of 2025.

In the UC cohort, duvakitug led to higher clinical remission rates compared to placebo in both advanced therapy-experienced and therapy-naïve patients. Additional endpoints such as clinical response, endoscopic improvement, and histological-endoscopic mucosal improvement were also observed.

For Crohn’s disease, the RELIEVE UCCD study showed that duvakitug led to higher endoscopic response rates compared to placebo in both advanced therapy-experienced and therapy-naïve patients. Additional endpoints including endoscopic remission, clinical remission, and clinical response were also observed.

Overall, duvakitug was well tolerated in both the UC and CD cohorts with no significant safety concerns noted. The drug is currently under clinical investigation, and its efficacy and safety have not been evaluated by any regulatory authority.

Inflammatory bowel disease, comprising UC and CD, are chronic conditions that cause GI tract inflammation leading to severe symptoms. The RELIEVE UCCD Phase 2b study was a 14-week trial that assessed the efficacy, safety, pharmacokinetics, and tolerability of duvakitug in adults with moderate-to-severe UC or CD. New data from the RELIEVE UCCD study show duvakitug’s efficacy and safety across different doses. Endpoints include clinical, endoscopic outcomes, and histological improvement. Phase 3 program planned for H2 2025, first Phase 2 study investigating TL1A’s impact on CD. Study randomized patients to two doses of duvakitug or placebo for UC or CD for 14 weeks. Primary endpoints are clinical remission in UC and endoscopic response in CD. Duvakitug targets TL1A signaling via DR3 and is in Phase 2b for UC and CD. Teva and Sanofi collaborate on duvakitug’s development and commercialization. New data from the RELIEVE UCCD study show duvakitug’s effectiveness and safety across different doses and subgroups, with new endpoints on clinical, endoscopic outcomes and histological improvement. Phase 3 program expected to start in H2 2025. A study on TEV-48574 in Ulcerative Colitis or Crohn’s Disease is ongoing. Duvakitug demonstrates efficacy and safety as an induction treatment for Crohn’s disease in adults. Learn more about Inflammatory Bowel Disease (IBD) and Ulcerative Colitis from the CDC. Additional resources are available on IBD from PubMed and MAbs.



Read more at GlobeNewswire: Teva and Sanofi Present New Positive Phase 2b Study Results