Sanofi: results of Crohn's disease study
(CercleFinance.com) - Sanofi and Teva Pharmaceuticals announce that the Phase IIb RELIEVE UCCD study has met its primary endpoints in patients with ulcerative colitis and Crohn's disease.
The RELIEVE UCCD study evaluated duvakitug, a humanized IgG1-λ2 monoclonal antibody targeting TL1A, for the treatment of moderate to severe inflammatory bowel disease (IBD).
In the RELIEVE UCCD study, 36.2% and 47.8% of ulcerative colitis patients treated with low- or high-dose duvakitug respectively achieved clinical remission, compared with 20.45% of patients treated with placebo.
This is the first and only randomised, placebo-controlled study to evaluate the effect of an anti-TL1A monoclonal antibody in the treatment of Crohn's disease.
Sanofi and Teva plan to launch a Phase III development program for the treatment of IBD, subject to the outcome of discussions with regulatory authorities.
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