Teva与Sanofi在UEG公布duvakitug（抗TL1A）Phase 2b长期维持期第44周阳性数据，UC/CD疗效持续

Teva Pharmaceutical Industries Ltd. (TEVA) and Sanofi (SNY) announced positive long-term Phase 2b data for investigational duvakitug, showing sustained improvements in ulcerative colitis (UC) and Crohn's disease (CD) through Week 44 of the RELIEVE UCCD long-term extension study.
Duvakitug is an investigational monoclonal antibody targeting TL1A, a protein involved in inflammation and potentially fibrosis in inflammatory bowel disease (IBD).
In patients with UC, clinical remission rates at Week 44 were 47% with the 450 mg dose and 58% with the 900 mg dose, administered subcutaneously every four weeks. Clinical response rates were 82% and 87%, respectively, while endoscopic improvement rates reached 59% and 63%.
In patients with CD, endoscopic response rates were 41% with the 450 mg dose and 55% with the 900 mg dose. Clinical response rates were 81% and 87%, respectively, while clinical remission rates reached 81% and 84%.
The study included 130 patients who responded to duvakitug during the 14-week induction study, comprising 72 patients with UC and 58 with CD. Participants were randomized to receive either 450 mg or 900 mg of duvakitug every four weeks during the maintenance period.
The companies said efficacy outcomes were numerically higher with the 900 mg dose across the reported endpoints, suggesting a potential dose-response relationship.
Biomarker analyses also showed reductions in markers associated with inflammation in both UC and CD. In Crohn's disease, treatment reduced markers linked to the Th17 and Th1 immune pathways and tissue remodeling, providing additional evidence supporting the potential of TL1A inhibition to address inflammation and possibly fibrosis.
Regarding safety, duvakitug was generally well tolerated during the maintenance period, with a safety profile consistent with the induction study and no new safety concerns identified. Most adverse events were mild or moderate, and discontinuation rates due to adverse events were low.
Based on the findings, duvakitug is being evaluated in Phase 3 SUNSCAPE-1 and SUNSCAPE-2 studies for UC and STARSCAPE-1 and STARSCAPE-2 studies for Crohn's disease. The companies have also initiated a Phase 2 study in hidradenitis suppurativa and are planning a Phase 2 study in fibrostenotic Crohn's disease.
Duvakitug remains investigational, and its safety and efficacy have not been reviewed or approved by any regulatory authority.
SNY is currently up 4.11% at $41.19.
TEVA is currently down 0.41% at $41.14.
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