A New Immuno-Resolving Treatment Paradigm for Inflammatory Bowel Disease (IBD)
IBD is a group of disorders characterized by inflammation and ulceration of the small and large intestines. The two major types of IBD are Ulcerative Colitis, which occurs in the colon and rectum, and Crohn’s Disease, which affects tissue throughout the intestinal tract.
First-line IBD therapy with 5-ASA and steroids is incompletely effective, with up to 50% of patients failing therapy. Currently, patients failing first-line therapy are escalated to more aggressive drugs that block key steps in the inflammatory cascade. This immunosuppressive approach can increase the risk of infection and cancer, and often has other significant side effects. In addition to this undesirable safety profile, intravenously-dosed biological therapies are expensive and inconvenient, and can lose efficacy over time. Thus, there is a clear need for safe, oral IBD therapies that are suitable for chronic administration in adult and pediatric patients.
Thetis has two IBD candidates in preclinical development. TP-317 is a new molecular entity that delivers Resolvin E1, a naturally occurring lipid that coordinates the resolution of inflammation and return to normal following an immune response. TP-317 has the potential to be a safe, first-in-class, oral therapy for patients failing first-line therapy before escalation to biologics. TP-252 is a unique salt derivative of eicosapentaenoic acid, which was shown in an academic Phase 2 trial to significantly reduce relapse in ulcerative colitis patients. TP-252 is targeted as adjunct over 5-ASA therapy to maintain remission and avoid escalation to step-up therapies.