Development of TP-317 for Ulcerative Colitis

What To Know

NIH Reporter describes a funded project by Thetis Pharmaceuticals to advance TP-317, a stabilized form of the endogenous lipid Resolvin E1 (RvE1), as an oral therapy aimed at promoting epithelial repair in ulcerative colitis.

Preclinical murine-colitis data and a completed Phase 1a single-ascending-dose study (10–80 mg) showing tolerability and plasma levels consistent with BLT1 activation are reported. The current proposal focuses on completing GLP toxicology (including a 6-month rat study) needed to support IND-enabling safety data and progression to Phase 2 trials.

TP-317 is formulated as a magnesium L-lysinate salt of RvE1 in a gamma-cyclodextrin complex and delivered as an enteric-coated tablet designed to release RvE1 in the upper intestine. The project frames BLT1 as a target for epithelial repair and immune homeostasis rather than conventional immunosuppression.

Planned next steps described include GLP toxicology completion and IND-enabling activities to support subsequent clinical development (Phase 1b in UC was planned for 2025 per the record). The entry is a project record describing funded preclinical and early clinical development rather than a peer-reviewed paper or finalized clinical results.

It summarizes the sponsor's development plan and prior Phase 1a tolerability data as presented in the NIH project description.