Teva and Sanofi present new outcome from Phase 2b study of duvakitug

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Sanofi presented new, detailed results from the RELIEVE UCCD Phase 2b study of duvakitug, a human IgG1-λ2 monoclonal antibody targeting TL1A, for the treatment of moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD).

The double-blinded, 14-week, dose-ranging study was designed to assess the safety, pharmacokinetics, tolerability and efficacy of the antibody in the adult population with this condition.

It demonstrated that subjects receiving the therapy showed significantly higher rates of clinical remission, the primary endpoint, at week 14 than those on a placebo in the UC cohort.

“Patients, many of whom have spent years in a recurring cycle of remission and relapse, have been waiting a long time for better options in treating ulcerative colitis. We’re highly encouraged by the significant treatment response, compared to placebo seen in the study, both in advanced therapy naïve-and experienced patients,” said Walter Reinisch, MD, PhD, Medical University of Vienna, and lead investigator of the RELIEVE UCCD study. “With this potential of duvakitug to reduce inflammation, we could truly transform treatment for patients with IBD in a safe manner.”

“Every day, I see patients with Crohn’s disease who continue to suffer from the often-severe symptoms of the disease despite available treatments,” said Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine in the Departments of Medicine, Epidemiology and Biostatistics at Western University, and lead investigator of the RELIEVE UCCD study. “The endoscopic response rates seen in this study support the potential of duvakitug as an effective new option for these who are in desperate need of relief.”

In both the UC and CD cohorts, duvakitug was generally well tolerated with no emergent safety signals observed. No dose dependent or adverse event (AE) pattern was observed for treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation or adverse events of special interest (AESIs).

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