Home > Gastroenterology > ECCO 2020 > Experimental Therapies: Study Results > Phase 2 results of first-in-class TL1A inhibitor

Phase 2 results of first-in-class TL1A inhibitor

Presented By
Dr S. Danese, Humanitas University, Italy
Conference
ECCO 2020
Trial
Phase 2, TUSCANY
In the phase 2a open-label TUSCANY study, PF-06480605 exhibited an acceptable safety and tolerability profile and statistically significant endoscopic improvement in participants with moderate-to-severe ulcerative colitis (UC) [1]. In UC, TNFα-like ligand 1A (TL1A), is upregulated at the site of active disease. PF-06480605 is a first-in-class fully human IgG1 monoclonal antibody targeting TL1A. In TUSCANY, participants received 7 doses of 500 mg intravenous PF-06480605 every 2 weeks and were then followed up for 14 weeks. Of the 50 participants who received PF-06480605, 42 completed the study. At week 14, statistically significant endoscopic improvement (Mayo endoscopic subscore ≤1 without friability) was observed in 38.2% of participants; 24% achieved remission (total Mayo score ≤2, with no individual subscore >1) and 10% endoscopic remission (Mayo endoscopic subscore 0). In participants with endoscopic improvement, normalisation towards a non-i...


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