The Crohn’s & Colitis Foundation is providing funding support to Thetis Pharmaceuticals for the continuing development of the novel oral therapy TP-317 for the treatment of inflammatory bowel disease (IBD).
“We very much appreciate the support of the Crohn’s & Colitis Foundation and their confidence in our team and the promise of our Resolvin-based therapy as a novel approach to treatment of IBD,” Gary Mathias, CEO of Thetis, said in a press release.
TP-317 is a novel and optimized formulation of the bioactive natural fatty molecule resolvin E1, which was first discovered by Charles Serhan, PhD, professor at Harvard University and researcher at Brigham and Women’s Hospital.
Resolvin E1, also known as RvE1, is a byproduct of omega-3 fatty acid metabolism and was found to have the ability to regulate several mechanisms involved in tissue inflammation and repair implicated in IBD progression. In contrast to other molecules that can inhibit immune-mediated damage, RvE1 can block the same processes without affecting the body’s natural and necessary immune defenses.
“Resolvin E1 is a potent bioactive lipid mediator produced locally in inflamed tissue to orchestrate resolution of inflammation, reduction of pain and tissue repair following initiation of an acute inflammatory response,” said Serhan, who is also scientific advisor to Thetis.
“In chronic inflammatory diseases such as IBD, defective resolution leads to unresolved inflammation, tissue damage, and pain. Novel therapeutic approaches leveraging the pharmacology of Resolvins offer a unique, non-immunosuppressive approach to treating IBD by activating intrinsic resolution mechanisms in the body,” he said.
Results from preclinical studies using several animal models of IBD demonstrated that TP-317 can significantly reduce the burden of disease symptoms, as well as relieve intestinal inflammation, support bowel tissue repair, and enhance immunological tolerance.
TP-317 was also shown to significantly impact the production of signaling molecules of IBD-related processes in tissue biopsies derived from ulcerative colitis patients.
These findings suggest that TP-317’s beneficial effect could be translated into the clinic, making it a potential oral therapy for IBD patients whose symptoms are not well-controlled with first-line therapies, according to the company.
“Based on its unique mechanism of action, TP-317 has the potential to address a critical unmet need within the IBD treatment paradigm for a safe, oral, first-line therapy for Crohn’s disease and for ulcerative patients that are not well controlled on mesalamine before escalation to biologics,” said Joshua Korzenik, assistant professor at Harvard Medical School, and director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital.
Caren Heller, MD, chief scientific officer of the foundation, added: “TP-317 represents a promising new therapeutic approach with the potential to address a significant unmet need for safe, oral therapy for patients living with Crohn’s disease and ulcerative colitis. We are excited to partner with Thetis as they advance their Resolvin-based therapy into clinical investigation.”