On December 17, Teva Pharmaceuticals and Sanofi announced that the targeted TL1A antibody duvakitug met the primary endpoint in a Phase 2b RELIEVE UCCD study in patients with ulcerative colitis (UC) and Crohn's disease (CD).
According to their press release, duvakitug showed the best efficacy results in high-dose treatment for UC and CD compared to all other TL1A monoclonal antibodies currently available.
Duvakitug (TEV'574/SAR447189) is a human IgG1-λ2 monoclonal antibody targeting TL1A, used for treating moderate-to-severe inflammatory bowel disease (IBD). On October 4, 2023, Sanofi entered into a partnership with Teva to jointly develop the TL1A antibody TEV'574. Under the agreement, Teva will receive approximately $500 million in upfront payments, along with up to $1 billion in milestone payments.
The RELIEVE UCCD study is a 14-week, Phase 2b, randomized, double-blind, dose-ranging study aimed at determining the efficacy, safety, pharmacokinetics, and tolerability of duvakitug in adult patients with moderate-to-severe ulcerative colitis (UC) or Crohn's disease (CD).
In the RELIEVE UCCD study, 36.2% (low dose) and 47.8% (high dose) of UC patients treated with duvakitug achieved clinical remission, while 20.45% of patients treated with placebo reached this endpoint. The adjusted remission rates at week 14 were 15.7% (low dose) and 27.4% (high dose) for the placebo group (p-values of 0.050 and 0.003, respectively).
In Crohn's disease patients, 26.1% (low dose) and 47.8% (high dose) of patients treated with duvakitug achieved an endoscopic response, while 13.0% of placebo-treated patients achieved this result. The adjusted endoscopic response rates at week 14 were 13.0% (low dose) and 34.8% (high dose) for the placebo group (p-values of 0.058 and <0.001, respectively).
Overall, the treatment effects were consistent across subgroups. This is the first and only randomized, placebo-controlled study assessing the impact of TL1A monoclonal antibodies on CD. Detailed results are expected to be presented at scientific forums in 2025.
Duvakitug demonstrated good tolerability in both UC and CD, with no safety signals identified. The incidence of adverse events (AEs) was similar for duvakitug and placebo in both UC and CD (50% vs 50%). All AEs reported in UC and CD were below 5%.
Sanofi and Teva plan to initiate Phase 3 clinical development for IBD. Upon the initiation of Phase 3 trials in UC and CD, TEVA will receive $250 million in development milestone payments for each indication.
Dr. Eric Hughes, Teva's Global Head of R&D and Chief Medical Officer, stated: "The results from the RELIEVE UCCD study exceeded our expectations, and duvakitug holds the potential to significantly improve the quality of life for IBD patients, which deeply moves me. These positive results reinforce Teva's capability to develop and accelerate the access to innovative therapies. We are excited to collaborate with our partner Sanofi to advance the next phase of development and thank the researchers and patients involved in this study."
Dr. Houman Ashrafian, Executive Vice President and Head of R&D at Sanofi, stated: "These unprecedented results suggest that duvakitug could represent the next frontier in the treatment of ulcerative colitis and Crohn's disease. If the effects observed in Phase 3 trials are sustained, we believe we will be able to offer differentiated therapies to IBD patients who are in urgent need of new options. The duvakitug program and this collaboration highlight Sanofi's strategy to identify and rapidly advance breakthrough therapies based on science."
As a result of this news, Teva's stock price surged by 26.47%!
