On Tuesday, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA ) and Sanofi SA’s (NASDAQ: SNY ) Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD) .
RELIEVE UCCD investigated duvakitug (TEV’574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A, for moderate-to-severe inflammatory bowel disease (IBD).
In the RELIEVE UCCD study, 36.2% (low-dose) and 47.8% (high-dose) of patients with ulcerative colitis treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14.
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In patients with Crohn’s disease, 26.1% (low-dose) and 47.8% (high-dose) treated with duvakitug achieved endoscopic response compared to 13.0% on placebo, placebo-adjusted rates were 13.0% (low dose) and 34.8% (high dose).
Overall, the treatment effect was consistent across subgroups.
Detailed results are expected to be presented at a scientific forum in 2025.
Duvakitug was generally well tolerated in ulcerative colitis and Crohn’s disease, with no safety signal identified.
Overall treatment-emergent adverse events (AE) rates were similar between duvakitug and placebo.
Ulcerative colitis and Crohn’s disease, the two main types of IBD, are chronic inflammatory conditions of the GI tract resulting in symptoms such as abdominal pain, diarrhea, rectal bleeding, fatigue, and weight loss.
Price Action: At last check Tuesday, TEVA stock was up 20.40% at $19.88, and SNY stock was up 4.07% at $47.76 during the premarket session.
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