TP-317 Program for Inflammatory Bowel Disease (IBD)
IBD is a collection of chronic, relapsing inflammatory gastrointestinal disorders that includes ulcerative colitis and Crohn’s Disease. Medical management of IBD primarily relies on anti-inflammatory and immunosuppressive pharmacotherapy, which have significant drawbacks, including incomplete efficacy, significant side effects and safety issues, and inconvenient parenteral administration.
TP-317 is a first-in-class oral therapy with a unique mechanism of action (MOA) based on promoting inflammation resolution, tissue repair and immunological tolerance without compromising immune function. TP-317 is a new molecular entity that delivers Resolvin E1 (RvE1), which has been shown to regulate multiple inflammatory processes implicated in IBD pathogenesis without compromising the body’s ability to fight infection. In multiple animal models of IBD, TP-317 has been shown to improve disease symptoms, ameliorate intestinal inflammation, promote mucosal tissue repair, and enhance immunological tolerance. In addition, TP-317 has demonstrated pronounced effects on cytokine and gene expression in patient derived biopsies, providing support that these findings will translate into the clinic.
Separate studies have demonstrated the ability of RvE1 to modulate cellular and molecular mechanisms implicated in IBD, including immune cell activation and trafficking and inflammatory cytokine signaling. RvE1 has also been shown to promote tissue repair and re-epithelialization, suggesting a role in mucosal healing. Finally, TP-317 has demonstration activation of regulatory T-cells, suggesting an ability to enhance immunological tolerance.
Based on these credentials, TP-317 has the potential to be a safe, oral therapy for induction and maintenance of remission in IBD patients that are not well-controlled on first-line 5-ASA therapy, a segment with limited therapeutic options other than escalating to potent immunosuppressive agents with major safety issues.