S Danese et al. The Lancet Gastroenterology & Hepatology 2025; 10: 882 – 895. 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

Briefly noted:

Methods: “The multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b, TUSCANY-2 trial” enrolled 228 people who completed induction. All patients had moderate to severe ulcerative colitis who were treated with either subcutaneous afimkibart (a TNF-like ligand 1A (TL1A)) or placebo. There was a 12-week induction phase followed by a 40-week maintenance phase.

Key findings:

• At week 14, the primary endpoint of clinical remission by total Mayo score was reported in 12 (26%) of 47 patients in the afimkibart 50 mg group, 14 (23%) of 60 patients in the afimkibart 150 mg group, and 21 (24%) of 88 patients in the in the afimkibart 450 mg group versus five (12%) of 43 patients in the placebo group
• Incidences of treatment-emergent adverse events during induction were similar with placebo and afimkibart
• The percentages of remission were higher for every afimkibart dose but this did not reach statistical significance compared to placebo

My take: Further testing is needed to determine whether afimkibart will have a significant place for treatment of inflammatory bowel disease.