Teva and Sanofi Share Positive Results from Phase II Study in Ulcerative Colitis and Crohn’s Disease
Duvakitug, a monoclonal antibody, demonstrated clinical remission and endoscopic response in the study, meeting its primary endpoints.
Teva and Sanofi have announced positive results from the Phase IIb RELIEVE UCCD study evaluating duvakitug (TEV’574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A, for the treatment of moderate-to-severe inflammatory bowel disease (IBD). The study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD).1
According to the results, 36.2% (low-dose) and 47.8% (high-dose) of patients with UC treated with duvakitug achieved clinical remission compared to just 20.45% in the placebo arm. In patients with CD, duvakitug once again achieved its primary endpoint—26.1% (low-dose) and 47.8% (high-dose) of patients achieved an endoscopic response compared to 13.0% on placebo.
In a press release, Eric Hughes, MD, PhD, head of global R&D and chief medical officer at Teva 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. These positive results reinforce Teva's ability to develop and accelerate access to innovative medicines. We are excited to collaborate on the next phase of development with our partner, Sanofi, and we would like to thank the investigators and patients who participated in this study.”
The Phase IIb RELIEVE UCCD trial is a 14-week randomized, double-blinded, dose-ranging study to determine the efficacy, safety, pharmacokinetics and tolerability of duvakitug in adults with moderate to severe UC or CD. Participants who completed the initial 14-week study were eligible to participate in a long-term extension study, which is currently ongoing. Responders from the 14-week study could enter a 44-week maintenance period to receive a low or high dose of duvakitug every four weeks. Non-responders could enter a 14-week re-induction period. Primary endpoints across both studies are clinical remission for the UC cohort and endoscopic response in the CD cohort.
“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 III program, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options,” Houman Ashrafian, MD, PhD, executive vice president, head of R&D at Sanofi, said in the press release. “The duvakitug program and this partnership underscore Sanofi’s strategy of following the science to identify and rapidly advance breakthrough medicines for patients.”
Reference
1. Teva and Sanofi Announce Duvakitug (Anti-TL1A) Positive Phase 2b Results Demonstrating Best-in-Class Potential in Ulcerative Colitis and Crohn’s Disease. News release. Teva. December 17, 2024. Accessed December 18, 2024. https://www.tevapharm.com/news-and-media/latest-news/teva-and-sanofi-announce-duvakitug-anti-tl1a-positive-phase-2b-results-demonstrating-best-in-class-pote/
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
