Teva and Sanofi reveal promising Phase 2b data for duvakitug in ulcerative colitis and Crohn’s disease

Teva Pharmaceutical Industries Ltd. and Sanofi have unveiled encouraging new data from their Phase 2b RELIEVE UCCD trial, highlighting the potential of duvakitug, a novel monoclonal antibody targeting TL1A, as a promising therapy for ulcerative colitis and Crohn’s disease. The results, presented at the 20th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Berlin, underscore the drug’s ability to induce clinical remission and endoscopic response in patients with inflammatory bowel disease (IBD), particularly those who have experienced limited success with existing treatments.

The findings indicate that duvakitug could represent a significant breakthrough in ulcerative colitis treatment and Crohn’s disease therapy, addressing an urgent need for more effective and well-tolerated treatment options. With plans to advance to Phase 3 trials later in 2025, the drug’s development is being closely monitored by both the medical community and investors.

What Did The Study Reveal About Duvakitug’s Effectiveness In Ulcerative Colitis?

The RELIEVE UCCD trial evaluated the safety and efficacy of duvakitug in patients with moderate-to-severe ulcerative colitis who had previously shown an inadequate response, loss of response, or intolerance to conventional and advanced therapies. The study, which utilized a randomized, double-blinded, placebo-controlled design, found that the treatment led to significant improvements in clinical remission rates compared to placebo.

At Week 14, 36% of patients receiving the 450 mg dose of duvakitug and 48% of those receiving the 900 mg dose achieved clinical remission, compared to just 20% in the placebo group. The placebo-adjusted rates were 16% for the lower dose and 27% for the higher dose, highlighting the drug’s robust efficacy. The trial also reported notable improvements in secondary endpoints, including clinical response rates, endoscopic improvement, and histological-endoscopic mucosal improvement.

Walter Reinisch, MD, PhD, from the Medical University of Vienna and lead investigator of the RELIEVE UCCD study, noted that the promising results could mark a turning point in ulcerative colitis treatment. He emphasized that many patients experience cycles of remission and relapse with current therapies, and the need for a more consistent and long-term solution remains critical. He suggested that duvakitug has the potential to address this gap by reducing inflammation more effectively while maintaining a favorable safety profile.

How Effective Is Duvakitug In Crohn’s Disease Therapy?

The trial also assessed the impact of duvakitug on Crohn’s disease therapy, demonstrating its ability to significantly improve endoscopic response rates in patients with moderate-to-severe disease. At Week 14, 26% of patients receiving the 450 mg dose and 48% of those receiving the 900 mg dose achieved endoscopic response, compared to just 13% in the placebo group. The placebo-adjusted improvements were 13% and 35%, respectively, with particularly strong responses seen among patients who had not previously received advanced therapy.

The data showed that duvakitug not only improved endoscopic response but also led to higher remission rates, with 50% of patients on the 450 mg dose and 54% of those on the 900 mg dose achieving clinical remission compared to 41% in the placebo group. Experts believe this suggests the drug could be a viable new option for Crohn’s disease therapy, offering hope to patients who have struggled with persistent symptoms despite available treatments.

Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, a professor at Western University and another lead investigator, emphasized the urgent need for innovative therapies for inflammatory bowel disease. He highlighted that many patients with Crohn’s disease face significant challenges in managing their symptoms, and the study’s findings indicate that duvakitug could provide an effective alternative for those who have exhausted existing options.

What Makes Duvakitug A Potential Best-In-Class Treatment?

Duvakitug is a human IgG1-λ2 monoclonal antibody that specifically targets TL1A, a key driver of inflammation and fibrosis in inflammatory bowel disease. Unlike conventional biologics, which broadly suppress immune activity, duvakitug is designed to selectively inhibit TL1A signaling through its receptor, death receptor 3 (DR3), while reducing off-target effects associated with TL1A-DcR3 inhibition. This unique mechanism of action is believed to contribute to its strong efficacy and favorable safety profile.

The study found that duvakitug was generally well tolerated, with no significant safety concerns emerging across different dosages. There were no patterns of dose-dependent adverse events, serious adverse events, or discontinuations due to safety concerns, further reinforcing the drug’s potential as a next-generation treatment for ulcerative colitis and Crohn’s disease.

What Are The Next Steps For Duvakitug’s Development?

With Phase 2b data confirming duvakitug’s promising efficacy and safety, Teva Pharmaceuticals and Sanofi are moving forward with a global Phase 3 clinical development program, which is expected to begin in the second half of 2025. Under the collaboration, Sanofi will lead the Phase 3 trials, while Teva will oversee commercialization in Europe, Israel, and select other markets. Sanofi will take charge of commercialization in North America, Japan, and additional regions.

The Phase 3 program will aim to validate the findings from the Phase 2b study and provide the necessary data for regulatory submissions. If successful, duvakitug could become one of the most significant advancements in ulcerative colitis treatment and Crohn’s disease therapy, offering a novel therapeutic option for patients worldwide.

What Does This Mean For Patients With Inflammatory Bowel Disease?

The introduction of duvakitug into the treatment landscape could have profound implications for patients with ulcerative colitis and Crohn’s disease, particularly those who have failed to achieve sustained remission with current therapies. The trial results indicate that the drug may offer a more targeted and effective approach to controlling inflammation, potentially leading to longer periods of disease remission and improved quality of life.

While regulatory approval is still pending, the strong Phase 2b results provide renewed hope for patients and healthcare professionals seeking better solutions for inflammatory bowel disease. The upcoming investor call on Monday, February 24 at 8:00 a.m. U.S. ET will provide further insights into the study’s findings and the future development plans for duvakitug.

As the medical community awaits the results of the upcoming Phase 3 trials, the potential for duvakitug to transform ulcerative colitis treatment and Crohn’s disease therapy remains a key area of interest. Should the drug continue to demonstrate best-in-class efficacy and safety, it could represent a major step forward in addressing the significant unmet needs of patients with inflammatory bowel disease.