Relieve UC Study Hits Primary Endpoints

In the RELIEVE UCCD study, 36.2% (low dose) and 47.8% (high dose) of patients with UC treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14 (p=0.050 and 0.003, respectively). In patients with CD, 26.1% (low dose) and 47.8% (high dose) treated with duvakitug achieved endoscopic response compared to 13.0% on placebo, placebo-adjusted rates were 13.0% (low dose) and 34.8% (high dose), at week 14 (p= 0.058 and <0.001, respectively). Overall, the treatment effect was consistent across subgroups. This is the first and only randomized, placebo-controlled study to evaluate the impact of an anti-TL1A monoclonal antibody in CD. Detailed results are expected to be presented at a scientific forum in 2025.

Duvakitug was generally well tolerated in both UC and CD with no safety signal identified. Overall rates of treatment emergent adverse events (AE) were similar between duvakitug and placebo across both UC and CD (50% vs 50%). All AEs reported across both UC and CD were less than 5%.

“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 program, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options,” said Houman Ashrafian, MD, PhD, Head of R&D at Sanofi. “The duvakitug program and this partnership underscore Sanofi’s strategy of following the science to identify and rapidly advance breakthrough medicines for patients.”

“The results from the RELIEVE UCCD study have exceeded our expectations, and I am deeply moved by the potential of duvakitug to help treat and meaningfully improve the quality of life of people living with IBD,” said Eric Hughes, MD, PhD, Head of Global R&D and Chief Medical Officer at Teva. “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.”

Duvakitug is currently under clinical investigation, and its efficacy and safety have not been evaluated by any regulatory authority.

About the RELIEVE UCCD phase IIb study - RELIEVE UCCD is a 14-week phase IIb, 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. In the study, patients who met pre-specified inclusion criteria were randomized to receive one of two duvakitug doses or placebo, administered every two weeks subcutaneously, in a 1:1:1 ratio for each indication (UC or CD) stratified by previous exposure to advanced IBD therapies for 14 weeks.

Participants who completed the 14-week induction study were eligible to participate in a long-term extension (LTE) study, currently ongoing. Responders from the induction study could enter the LTE directly into a 44-week maintenance period to receive a low or high dose every four weeks. Non-responders could enter a 14-week re-induction period. Responders to re-induction entered the 44-week maintenance period. Participants who responded during the maintenance period are eligible for an open-label period within the LTE. Primary efficacy endpoints for both the 14-week induction study and the 44-week maintenance study are the number of participants who show clinical remission (as defined by the modified Mayo score) in the UC cohort or the number of participants who show endoscopic response (as defined by the SES-CD endoscopic score for CD) in the CD cohort. The study includes sites in the US, Europe, Israel, and Asia.