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Phase 2 results of first-in-class TL1A inhibitor

Presented by
Dr S. Danese, Humanitas University, Italy
ECCO 2020
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-inflamed transcriptome was demonstrated.

There were 109 treatment-emergent adverse events (AEs), 18 of which were deemed related to treatment. Aside from worsening UC, the most common treatment-emergent AE was arthralgia, which occurred in 6 participants, and was thought to be treatment-related in 1. Four treatment-emergent serious AEs were reported in 3 participants, 1 of which (alopecia) was thought to be treatment-related. There were no malignancies or deaths.

      1. Danese S, et al. ECCO-IBD 2020, DOP72.

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