Development of a prototype formulation for TP-317, an oral, first-in-class, small molecule therapy for treatment of ulcerative colitis (UC).

Thetis is developing TP-317 as a safe, oral therapy for ulcerative colitis patients whose disease is incompletely controlled by first-line therapy that would be an alternative to aggressive immuno-suppressive therapies. 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 colon, TP-317 is expected to activate the body’s innate ability to resolve inflammation and repair damaged tissue. TP-317 has demonstrated significant therapeutic potential in animal models of IBD. The proposed project will support the development of a prototype pill that targets TP-317 delivery to the colon, a critical milestone for advancing TP-317 into clinical investigation. Aim-#1 includes TP-317 API synthesis, stability testing and characterization. Aim-#2 includes formulation feasibility studies and prototype tablet development. Aim-#3 characterizes the release profile of the prototype.