Program Related Investment for a Study to Investigate Biomarkers Associated with TP-317 Treatment in IBD.

The project will use mouse models of colitis to investigate the effects of TP-317 (Resolvin E1 magnesium lysinate) in blood, feces and intestinal tissue on key biomarkers that are involved in IBD pathophysiology and that Resolvin E1 has been shown to regulate in prior experiments. Key biomarkers of interest include (a) cytokines such as G-CSF, GM-CSF, IFN-γ, IL-10, IL-12p40, IL-12p70, IL-15, IL-17A, IL-8, IL-1β, IL-2, IL-23, IL-6, TGF-β1 and TNF-α; (b) intestinal alkaline phosphatase, a protein that plays a role in maintaining gut homeostasis and (c) Lipocalin-2 (LCN2), a marker of inflammation in feces. Unbiased RNA sequencing of tissue also will be conducted to identify novel biomarkers. Lastly, the study will evaluate the relationship between disease activity and biomarker response to identify potential biomarkers for clinical investigation.