Teva Pharmaceuticals and Sanofi announced positive Phase 2b results for duvakitug, a novel antibody targeting TL1A, in patients with moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). The RELIEVE UCCD study demonstrated that duvakitug achieved clinical remission in a significant portion of UC patients and endoscopic response in CD patients, exceeding placebo rates. The findings support the initiation of a Phase 3 program planned for the second half of 2025.
These results are potentially groundbreaking for IBD treatment. Current therapies often fail to achieve sustained remission or are associated with significant side effects. Duvakitug’s performance in both advanced therapy-experienced and -naïve patients suggests its potential to address unmet needs across a broad patient population. The safety profile, showing the drug was well-tolerated without new safety signals, further strengthens its potential as a valuable treatment option.
In the UC cohort, duvakitug achieved clinical remission rates of 36% (450mg dose) and 48% (900mg dose) compared to 20% for placebo. Additional endpoints like clinical response and endoscopic improvement also favored duvakitug. In the CD cohort, endoscopic response rates reached 26% (450mg) and 48% (900mg) versus 13% for placebo, with improvements also observed in endoscopic remission and clinical measures. Importantly, no dose-dependent adverse events were observed.
The positive Phase 2b data for duvakitug mark a crucial step towards a potential new therapeutic option for IBD. The planned Phase 3 program will be essential for confirming the efficacy and safety observed in this study and for defining duvakitug’s place in the IBD treatment landscape. If successful, duvakitug could offer a much-needed new approach to managing these chronic conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
