Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries, and Sanofi have announced positive results from the Phase 2b RELIEVE UCCD study of duvakitug (TEV’574/SAR447189).
The study tested duvakitug for treating moderate-to-severe inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).
Duvakitug, a monoclonal antibody targeting TL1A, met its primary endpoints in the trial.
In the RELIEVE UCCD study, duvakitug showed significant improvements in patients with UC and CD.
Among UC patients, 36.2% (low dose) and 47.8% (high dose) achieved clinical remission by week 14, compared to 20.45% on placebo.
For CD patients, 26.1% (low dose) and 47.8% (high dose) achieved endoscopic response, compared to 13% on placebo.
This marks the first randomised, placebo-controlled study of an anti-TL1A monoclonal antibody in CD, with detailed results to be presented at a scientific forum in 2025.
Duvakitug was generally well tolerated in both UC and CD, with no safety signals identified.
The overall rates of treatment-emergent adverse events (AEs) were similar between duvakitug and placebo in both UC and CD.
Teva chief medical officer and global research and development (R&D) head Eric Hughes 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.”
Teva and Sanofi are collaborating to co-develop and co-commercialise duvakitug for treating UC and CD. The French drugmaker licensed the asset from Teva in a deal valued at around $1.5bn in October last year.
The companies will equally share global development costs and net profits and losses in major markets, with a royalty arrangement in other markets.
Sanofi will lead the Phase 3 clinical development, while Teva will handle commercialisation in Europe, Israel, and select countries. Sanofi will lead commercialisation in North America, Japan, other parts of Asia, and the rest of the world.
Both companies plan to begin Phase 3 development in IBD, pending regulatory discussions.
Sanofi R&D head and executive vice president Houman Ashrafian said: “These unprecedented results show that duvakitug could represent the next frontier in treating ulcerative colitis and Crohn’s disease.
“If the magnitude of effect persists in the Phase 3 programme, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options.”
