Duvakitug Phase 2b Shows Promising Results for Ulcerative Colitis and Crohn's

PARIS, France and Parsippany, NJ, USA, December 17, 2024 – Sanofi and Teva Pharmaceuticals have announced promising findings from the RELIEVE UCCD phase 2b clinical trial, which evaluated duvakitug, a human monoclonal antibody, for treating ulcerative colitis (UC) and Crohn’s disease (CD). This study marks a significant step forward in addressing moderate-to-severe inflammatory bowel disease (IBD), having successfully met its primary endpoints.

The RELIEVE UCCD trial specifically investigated the efficacy of duvakitug, which targets TL1A, a factor involved in amplifying inflammation and fibrosis in IBD. The study reported that 36.2% of UC patients on a low dose and 47.8% on a high dose of duvakitug achieved clinical remission, compared to 20.45% of those on a placebo. The placebo-adjusted remission rates were 15.7% for the low dose and 27.4% for the high dose, with statistical significance noted at week 14 (p=0.050 for low dose and 0.003 for high dose).

For participants with CD, 26.1% on a low dose and 47.8% on a high dose of duvakitug experienced an endoscopic response, compared to 13% on placebo. The placebo-adjusted response rates were 13% for the low dose and 34.8% for the high dose, with statistically significant results at week 14 (p= 0.058 for low dose and <0.001 for high dose). Importantly, this trial is the first of its kind to assess an anti-TL1A antibody in a randomized, placebo-controlled manner for CD, with comprehensive results expected to be shared at a scientific conference in 2025.

In terms of safety, duvakitug was generally well tolerated across both UC and CD groups, with adverse events comparable to those observed in the placebo group (50% occurrence in both cases). Notably, none of the adverse events exceeded a 5% occurrence rate in any group.

Houman Ashrafian, MD, PhD, Executive Vice President and Head of Research & Development at Sanofi, expressed optimism about the results, noting that duvakitug could be transformative for patients dealing with UC and CD. The objective is to continue advancing this promising treatment through the phase 3 program, potentially offering a novel therapeutic option for those with IBD.

Eric Hughes, MD, PhD, Teva’s Head of Global Research & Development and Chief Medical Officer, conveyed enthusiasm about the promising results and their implications for improving the quality of life for individuals with IBD. Teva is committed to accelerating the development and availability of innovative treatments in collaboration with Sanofi.

Duvakitug is currently in clinical trials and has not yet been approved by any regulatory authority. The ongoing RELIEVE UCCD trial spans 14 weeks and involves a double-blind, randomized, dose-ranging approach to assess the drug's efficacy, safety, pharmacokinetics, and tolerability in adults with moderate to severe UC or CD. Participants receive either one of two doses of duvakitug or a placebo every two weeks.

Moreover, patients who complete the initial 14-week study have the opportunity to join a long-term extension study, which includes a maintenance period and options for re-induction based on individual response. The study involves diverse sites across the US, Europe, Israel, and Asia.

Duvakitug is distinguished by its targeted mechanism, which aims to disrupt the TL1A signaling pathway known to exacerbate inflammation and fibrosis in IBD. This antibody is currently being evaluated for its potential as a pioneering treatment for UC and CD.

Sanofi and Teva are jointly developing and commercializing duvakitug, dividing global development costs and sharing profits and losses in major markets. Sanofi is leading the phase 3 clinical development efforts, while Teva will oversee commercialization in Europe, Israel, and select countries, with Sanofi managing commercialization in North America, Japan, and other regions.