Rosnilimab — Ulcerative Colitis
In Q4 2023, we initiated a global Phase 2 trial of rosnilimab for the treatment of moderate-to-severe ulcerative colitis
Top-line data through Week 12, including primary and key secondary endpoints, on track for Q4 2025
Pathogenic T cells broadly impact multiple clinically validated drivers of UC pathogenesis
>40% of T cells in lamina propria in UC are pathogenic
2x increase of pathogenic T cells observed in blood vs. healthy controls1
Adapted from Gastroenterology & Hepatology Volume 18, Issue 8 August 2022. 1. Chen et al, Clinical and Translational Immunology, 2024.
Tph impact seen in RA Phase 2b trial relevant to UC biology and correlates to reduction of remission
Parmley et. al. UEGW 2024. October 2024
1. PD-1high Tph cells defined by CD3+CD4+CD45RA-PD-1+TIGIT+ICOS+CXCR5-. Long et al, Immunology Letters 233 (2021) 2-10.; 2. Rao et al, Nature, 2017. *** p<0.001, * p<0.05; 3. Rosnilimab formatted to mIgG2a to mediate effector function in mice. Suzuki et al., Sci. Immunol. 8, eadd4947 (2023); 4. Reduction of Tfh/Tph cells should impact plasma cell generation and autoantibody levels, including anti-microbial IgG antibodies that are contributing to colonic inflammation and barrier disruption: Uzzan et al, Nature, 2022.
Rosnilimab’s potent depletion of pathogenic T cells reduces T cell proliferation and inflammatory cytokines that disrupt barrier function
Parmley et. al. UEGW 2024. October 2024; Anti-CD3+ anti-CD28 stimulation of UC patient PBMCs for assessment of depletion and agonism MOA, representative data from N=6 donors; Rosnilimab IgG1 LALA included to demonstrate importance of Fc effector function.
To learn more about our clinical trial for Ulcerative Colitis please click here.