Thetis is developing TP-317 as a safe, oral therapy for treatment of ulcerative colitis and Crohn’s Disease. TP-317 is a novel derivative of Resolvin-E1, a molecule that is produced naturally by the body to regulate inflammation and promote healing. By delivering Resolvin-E1 to the small intestine and colon, TP-317 activates natural pathways to resolve inflammation and repair damaged tissue without suppressing the immune system. A previous KRF grant supported the development of a prototype oral capsule formulation of TP-317. The current grant proposal supports the manufacture of clinical trial material for early clinical development. The proposed grant is a supplement to the KRF off-cycle grant that Thetis received in August 2018, which funds the development of a TP-317 prototype oral formulation. In Aim #1, Thetis will synthesize and qualify drug substance under current good manufacturing practices (cGMP). In Aim #2, Thetis will manufacture cGMP drug product for early clinical studies utilizing the prototype being developed from the prior KRF grant. In Aim #3, Thetis will submit an investigational new drug (IND) application for initiation of Phase 1 clinical trials.