TP-317 for Treatment of IBD

TP-317 is being developed as first-line oral therapy for mild-to-moderate Crohn’s disease and as second-line oral therapy for patients with mild-to-moderate ulcerative colitis who are not well controlled on 5-ASA or corticosteroids.

Unmet Need

Due to the lack of a safe, effective oral drug, IBD patients with mild-to-moderate disease often turn to immuno-suppressive drugs such as biologics that increase the risk of serious infection and malignancy and have side effects that reduce quality of life.

Preclinical Evidence

RvE1 has shown efficacy in multiple preclinical colitis models including DSS, TNBS, TNF ΔARE and T-cell transfer. Mechanistically, RvE1 has been shown to shift the intestinal mucosa towards immune homeostasis and promote intestinal barrier repair, a key driver and measure of efficacy in human IBD.

Label Expansion

Based on its novel mechanism of action and anticipated safety, TP-317 has prospects to be used as adjunct to biologics and immuno-modulators to improve efficacy for induction and maintenance of remission in IBD patients with moderate-to-severe disease.