Teva Pharmaceutical Industries (TEVA) Study result summary

Study background and unmet need

• Less than 50% of patients with ulcerative colitis or Crohn's disease achieve clinical remission with current advanced therapies, and many lose responsiveness within a year.

• Up to 20% of ulcerative colitis and 75% of Crohn's disease patients require surgery despite treatment, highlighting the need for more durable and effective therapies.

• IBD, including UC and CD, affects about 4.9 million people globally and is characterized by chronic GI inflammation.

Duvakitug mechanism and design

• Duvakitug is a potent, selective human IgG1 monoclonal antibody targeting TL1A-DR3 signaling, sparing TL1A-DcR3 binding.

• Designed for high potency, selectivity, and low immunogenicity, and developed in collaboration with Sanofi.

• Believed to reduce inflammation and fibrosis in IBD.

Phase II/IIb study design and induction results

• The phase IIb program included a 14-week induction and a 44-week maintenance phase for UC and CD, using 900 mg and 450 mg doses versus placebo.

• Induction results showed robust placebo-adjusted deltas: 27.4% for UC and 34.8% for CD at 900 mg, with clear dose responses.

• Both treatment-naive and experienced patients responded similarly, and the safety profile was favorable with low anti-drug antibody rates (3%-5%).