Sanofi and Teva's Duvakitug Demonstrates Durable Efficacy in Phase 2b Maintenance Study for Ulcerative Colitis and Crohn's Disease

Duvakitug, a human monoclonal antibody targeting TL1A, demonstrated clinically meaningful durable clinical and endoscopic efficacy maintained over 44 weeks in patients with ulcerative colitis and Crohn's disease in the RELIEVE UCCD long-term extension study.

The drug maintained benefits in patients who initially responded to the 14-week induction phase, with efficacy demonstrated over a total of 58 weeks of treatment.

Duvakitug preferentially inhibits TL1A-DR3 signaling over DcR3 binding, with the potential to reduce inflammation and fibrosis associated with IBD.

The drug is currently in phase 3 clinical studies, including the STARSCAPE-1 and STARSCAPE-2 trials for Crohn's disease and SUNSCAPE-1 and SUNSCAPE-2 trials for ulcerative colitis.

Sanofi and Teva entered into an exclusive collaboration in October 2023 to co-develop and co-commercialize duvakitug, with Sanofi paying $500 million upfront and potentially receiving up to $1 billion in development and launch milestones.

The trial enrolled sites across the US, Europe, Israel, and Asia.

Duvakitug competes with rival anti-TL1A antibodies including Merck's tulisokibart and Roche's afimkibart, both also in phase 3 development.

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