New Data Emerges from Phase IIb RELIEVE UCCD Study in Ulcerative Colitis and Crohn’s Disease

Image Credit: © Sebastian Kaulitzki - stock.adobe.com

Teva and Sanofi have shared additional data from the Phase IIb RELIEVE UCCD study evaluating duvakitug (TEV’574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A, for the treatment of moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). The results of the trial were presented at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO) in Berlin, Germany.¹

Initially shared in December 2024, 36% (450 mg dose) and 48% (900 mg dose) of study participants in the UC cohort achieved the primary endpoint of clinical remission at week 14 with duvakitug treatment compared to 20% treated with placebo.

New data from both advanced therapy (AT)-experienced and AT-naïve subgroups of patients once again show higher rates of clinical remission compared to placebo:

• AT-experienced: 29% (450 mg) and 36% (900 mg)
• AT-naïve: 39% (450 mg) and 53% (900 mg)

In a press release, Walter Reinisch, MD, PhD, Medical University of Vienna, and lead investigator of the RELIEVE UCCD study said, “Patients, many of whom have spent years in a recurring cycle of remission and relapse, have been waiting a long time for better options in treating ulcerative colitis. We’re highly encouraged by the significant treatment response, compared to placebo seen in the study, both in advanced therapy naïve-and experienced patients. With this potential of duvakitug to reduce inflammation, we could truly transform treatment for patients with IBD in a safe manner.”

In the CD cohort, 26% (450 mg) and 48% (900 mg) of patients treated with duvakitug achieved the primary endpoint of endoscopic response compared to 13% on placebo. Emerging data from the AT-experienced and -naïve subgroups of patients are consistent with the initial results, once again showing higher endoscopic response rates compared to placebo:

• AT-experienced: 11% (450 mg) and 48% (900 mg)
• AT-naïve: 47% (450 mg) and 47% (900 mg)

Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine in the Departments of Medicine, Epidemiology and Biostatistics at Western University, and lead investigator of the RELIEVE UCCD study, added, “Every day, I see patients with Crohn’s disease who continue to suffer from the often-severe symptoms of the disease despite available treatments. The endoscopic response rates seen in this study support the potential of duvakitug as an effective new option for these who are in desperate need of relief.”

In both cohorts, duvakitug was generally well tolerated. There were no dose dependent or adverse event (AE) patterns observed for treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation, or adverse events of special interest (AESIs).

In an earlier press release highlighting the initial RELIEVE UCCD results, Eric Hughes, MD, PhD, head of global R&D and chief medical officer at Teva, said, “The results from the RELIEVE UCCD study have exceeded our expectations, and I am deeply moved by the potential for duvakitug to help treat and meaningfully improve the quality of life of people living with IBD. These positive results reinforce Teva's ability to develop and accelerate access to innovative medicines. We are excited to collaborate on the next phase of development with our partner, Sanofi, and we would like to thank the investigators and patients who participated in this study.”²

According to Teva and Sanofi, findings from the RELIEVE UCCD study will form the basis for a Phase III program expected to start in the second half of 2025.

References

1. Teva and Sanofi Present New Positive Phase 2b Study Results at ECCO 2025 Reinforcing Best-in-Class Potential of Duvakitug (Anti-TL1A) in Ulcerative Colitis and Crohn’s Disease. News release. Teva. February 22, 2025. Accessed February 25, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-and-Sanofi-Present-New-Positive-Phase-2b-Study-Results-at-ECCO-2025-ReinforcingBest-in-Class-Potential-of-Duvakitug-Anti-TL1A-in-Ulcerative-Colitis-and-Crohns-Disease/default.aspx

2. Teva and Sanofi Announce Duvakitug (Anti-TL1A) Positive Phase 2b Results Demonstrating Best-in-Class Potential in Ulcerative Colitis and Crohn’s Disease. News release. Teva. December 17, 2024. Accessed February 25, 2024. https://www.tevapharm.com/news-and-media/latest-news/teva-and-sanofi-announce-duvakitug-anti-tl1a-positive-phase-2b-results-demonstrating-best-in-class-pote/