Sanofi (SNY.US) and Teva (TEVA.US) are jointly developing Duvakitug, which is expected to initiate Phase 3 clinical trials in the second half of the year.

Sanofi (SNY.US) and Teva (TEVA.US) recently announced detailed results of the Phase 2b clinical trial RELIEVE UCCD for the investigational monoclonal antibody duvakitug that they co-developed. The trial results showed that patients with ulcerative colitis (UC) and Crohn's disease (CD) achieved remission at week 14 after receiving duvakitug treatment. The press release stated that these results demonstrate the potential for duvakitug to become a "best-in-class" therapy. The two companies expect to initiate Phase 3 clinical trials in the second half of this year. Data from the Phase 2b clinical trial showed that in UC patients treated with duvakitug, 36% in the low-dose group and 48% in 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 for the low-dose and high-dose groups were 16% (p=0.050) and 27% (p=0.003), respectively. Additionally, 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), while it was 23% in the placebo group. In CD patients, 26% in the low-dose group and 48% in the high-dose group achieved the primary endpoint of endoscopic remission, compared to 13% in the placebo group. After placebo correction, the endoscopic remission rates at week 14 for the low-dose and high-dose groups were 13% (p=0.058) and 35% (p<0.001), respectively. Duvakitug is a potential "best-in-class" human IgG1-2 monoclonal antibody that targets TL1A. TL1A amplifies inflammatory responses and accelerates the progression of fibrosis associated with IBD by binding to its receptor DR3. Targeting TL1A is expected to alleviate excessive immune responses in IBD patients. Sanofi and Teva reached a partnership agreement in 2023 to co-develop and commercialize duvakitug for the treatment of UC and CD. Sanofi leads the Phase 3 clinical development project, while Teva is responsible for the commercialization of the product in Europe, Israel, and select countries and regions. Sanofi is responsible for commercialization in North America, Japan, other Asian regions, and other global markets.