Module 2.7.5 — Literature References (TILA-278)

Document ID: M275
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4E(R2)

2.7.5 Literature References — TILA-278

Key references cited across the clinical summaries for TILA-278 in Ulcerative Colitis (moderate-to-severe), including the disease epidemiology and unmet need, the bispecific monoclonal antibody mechanism and class data, the endpoint validation (Modified Mayo Score), and the relevant regulatory guidance. Full citations accompany each Module 2.5/2.7 and Module 5 document.