Drug intelligence / Profile preview

afimkibart

Development stage
Phase 3
Lead developer
Roche
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous, Intravenous
01

Overview

Afimkibart is an investigational **anti-TL1A monoclonal antibody** being developed primarily by Roche for immune-mediated inflammatory diseases, especially inflammatory bowel disease. It binds and inhibits tumor necrosis factor-like ligand 1A, a cytokine also known as TNFSF15, with the therapeutic goal of reducing intestinal and systemic inflammation and potentially modulating fibrosis/scarring pathways. The asset originated as PF-06480605, later became RVT-3101 under Roivant and Telavant, and is now being advanced by Roche as afimkibart after Roche acquired rights in the Televant transaction. Publicly described development includes Phase III programs in ulcerative colitis and Crohn's disease, pediatric Phase III development in ulcerative colitis, and additional studies in atopic dermatitis, rheumatoid arthritis, and MASH liver fibrosis. Reported Phase IIb ulcerative colitis data from the TUSCANY-2 study supported continued development, with a generally favorable benefit-risk profile and signals of clinical activity.

Brand names
Afimkibart
Other names
anti-TL1A antibodyanti-TL-1A antibodyanti-TL 1A antibody
02

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