▎WuXiEdited by Kant Content Team

Sanofi and Teva Pharmaceuticals recently announced detailed results from the Phase 2b clinical trial RELIEVE UCCD for their jointly developed investigational monoclonal antibody duvakitug. The trial results showed,Patients with ulcerative colitis (UC) and Crohn's disease (CD) treated with duvakitug achieved remission at week 14.The press release stated that this result demonstrated the potential of duvakitug to become a "best-in-class" therapy. The two companies anticipate initiating Phase 3 clinical trials in the second half of this year.

UC and CD are the two main types of inflammatory bowel disease (IBD), which are chronic inflammatory conditions of the gastrointestinal (GI) tract that can cause symptoms such as abdominal pain, diarrhea, rectal bleeding, fatigue, and weight loss. Long-term inflammation can lead to complications like fibrosis, which refers to the excessive accumulation of scar tissue in the intestinal wall, potentially causing intestinal narrowing and obstruction. Patients often require hospitalization or surgical intervention. Currently, there is no cure for IBD, and the treatment goal is to induce and maintain remission while preventing disease recurrence.

Phase 2b clinical trial data shows,In UC patients treated with duvakitug, 36% of the low-dose group and 48% of the high-dose group achieved clinical remission, compared to only 20% in the placebo group.After placebo correction, the clinical remission rates at Week 14 were 16% (p=0.050) for the low-dose group and 27% (p=0.003) for the high-dose group.

In addition, the clinical response rates in the duvakitug group were 81% (low-dose group) and 70% (high-dose group), compared to 52% in the placebo group. The endoscopic improvement rates in the duvakitug group were 45% (low-dose group) and 50% (high-dose group), compared to 23% in the placebo group.

In CD patients, 26% of the low-dose group and 48% of the high-dose group reached the primary endpoint of endoscopic remission, compared to 13% in the placebo group.After placebo correction, the endoscopic remission rates at week 14 were 13% (p=0.058) for the low-dose group and 35% (p<0.001) for the high-dose group.

Duvakitug is a potential "best-in-class" human IgG1-λ2 monoclonal antibody targeting TL1A. TL1A amplifies inflammatory responses and accelerates the progression of IBD-related fibrosis by binding to its receptor DR3.Targeting TL1A holds promise in alleviating excessive immune responses in IBD patients. Sanofi and Teva Pharmaceutical Industries Ltd. entered into a collaboration in 2023 to co-develop and commercialize duvakitug for the treatment of UC and CD. Sanofi leads the Phase 3 clinical development program. Teva is responsible for the commercialization of the product in Europe, Israel, and selected countries/regions, while Sanofi oversees commercialization in North America, Japan, other Asian regions, and additional global markets.

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