Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): A multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, Phase 2b trial
Lancet Gastroenterol Hepatol 2025;10:882–95 Doi: 10.1016/S2468-1253(25)00129-3
Danese et al. report that in the TUSCANY-2 study, afimkibart showed a favourable
benefit–risk profile with clinically meaningful improvements and early onset of response during induction, sustained through maintenance, and an acceptable safety profile with no safety signals. Danese et al. describe results from the Phase 2b TUSCANY-2 trial that evaluated the safety and efficacy of 50mg, 150mg, and 450mg doses of afimkibart in adults with moderately-to-severely active UC.
Differences in the primary endpoint of clinical remission by total Mayo score were not significantly different for any dose of afimkibart compared with PBO. However, secondary endpoints suggest that afimkibart was associated with a favourable benefit–risk profile, with clinically meaningful improvements in clinical remission with the modified Mayo score for patients with moderately-to-severely active UC. These results support the continued development of afimkibart.
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