Teva and Sanofi’s phase 2b maintenance data shows promising results

In the recently conducted RELIEVE UCCD LTE phase 2b study, duvakitug exhibited substantial and sustained efficacy in patients with ulcerative colitis (UC) and Crohn’s disease (CD) over an additional 44-week period. The investigational human monoclonal antibody targeting TL1A was found to be well tolerated with safety consistent with previous studies. These positive results reinforce the potential of duvakitug, which is currently undergoing phase 3 programs for UC and CD. Teva Pharmaceuticals, in conjunction with Sanofi, shared these promising findings derived from the study.

The RELIEVE UCCD LTE study is a double-blind randomized trial aimed at assessing the long-term efficacy, safety, and tolerability of duvakitug in patients with UC and CD, the two most prevalent forms of inflammatory bowel disease (IBD). These extended data build upon the positive outcomes observed in the RELIEVE UCCD phase 2b induction study, demonstrating the clinical benefits of duvakitug compared to a placebo by week 14. According to Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva, the challenge in managing UC and CD lies not only in achieving an initial response but in maintaining it. These phase 2b results reaffirm TL1A as a promising target and underscore duvakitug’s potential as a leading therapeutic option for these conditions.

In the trial, 130 patients who had responded favorably to duvakitug during the induction study transitioned into a 44-week maintenance period. Patients were randomly assigned to receive either a 450 mg or 900 mg subcutaneous dose of duvakitug every four weeks for a total treatment duration of 58 weeks. By the end of the 44-week maintenance period, a significant proportion of patients with UC and CD achieved the primary endpoints of clinical remission and endoscopic response, respectively. Both doses of duvakitug were found to be well tolerated, with the most common adverse events aligning with those observed in previous trials.

Houman Ashrafian, Executive Vice President, Head of Research and Development at Sanofi, emphasized that these results highlight duvakitug as a promising therapy for UC and CD, offering long-term benefits for patients living with these debilitating conditions. With phase 3 studies currently underway, the focus remains on advancing duvakitug as a viable treatment option for individuals in need of new therapeutic alternatives.

IBD is an autoimmune disorder characterized by chronic inflammation of the gastrointestinal (GI) tract, affecting millions of individuals worldwide. UC and CD, the primary forms of IBD, present with symptoms such as persistent diarrhea, rectal bleeding, and abdominal pain. The condition can lead to complications such as fibrosis, resulting in intestinal damage. While there is currently no cure for IBD, treatment aims to induce and maintain remission in patients.

The RELIEVE UCCD program consists of an induction study and a long-term extension, with both phases designed to evaluate the efficacy, safety, and tolerability of duvakitug in patients with UC and CD. The positive outcomes observed in the study hold promise for the future of IBD treatment and underscore the therapeutic potential of duvakitug as a leading option for individuals living with UC and CD.