Thetis Pharmaceuticals Progressing to Clinic with a Phase 1 Trial of TP-317 for Treatment of Mild-to-Moderate Inflammatory Bowel Disease (1/16/2024)
First-in-human study to investigate TP-317 safety, tolerability and pharmacokinetics in healthy subjects as the first solid oral dosage form of a Resolvin E1-based drug.
ESSEX, CT – (January 16, 2024) – Thetis Pharmaceuticals LLC (“Thetis”), a biopharmaceutical company developing a first-in-class, oral small molecule Resolvin E1-based drug to treat chronic inflammatory diseases and cancer announced today that its Australian subsidiary, Thetis Pharma Pty Ltd., has received Ethics Committee approval to commence a Phase I clinical trial of TP-317 in Australia.
The trial will examine several oral doses of TP-317 formulated as a proprietary enteric-coated tablet of Resolvin E1 (“RvE1”) given to healthy volunteers. A key objective of the study is establishing the drug’s pharmacokinetic profile to enable selection of oral doses to advance into an efficacy study in patients with mild-to-moderate ulcerative colitis.
About TP-317
Overview: TP-317 is a patented small molecule drug that delivers Resolvin E1, an endogenous lipid mediator that activates BLT1 to regulate immune homeostasis. Unlike anti-inflammatory drugs and anti-cancer agents that are immuno-suppressive, TP-317 activates innate and adaptive immune pathways to treat disease without compromising host-protective immunity.
IBD Program: TP-317 is being developed in IBD as first-line, oral therapy for mild-to-moderate Crohn’s disease and as second-line, oral therapy for mild-to-moderate ulcerative colitis in patients who are not well controlled on 5-ASA or corticosteroids. TP-317 also has potential to treat moderate-to-severe IBD as adjunct therapy to standard-of-care biologics or oral immunomodulators. The anticipated high safety premium for TP-317 further supports early intervention in IBD and other immune disorders.
Cancer Program: TP-317 is being developed in cancer as an adjunct to standard of care therapy in refractory metastatic melanoma, advanced non-small-cell lung cancer (NSCLC), and pancreatic cancer. Preclinical studies with oral TP-317 in tumor models of these cancers have shown potent single-agent activity, and enhanced efficacy when combined with immune checkpoint inhibitors or chemotherapy.
About Thetis Pharmaceuticals
Thetis is a biopharmaceutical company dedicated to improving the lives of patients suffering from cancer and chronic inflammatory diseases. Thetis’ proprietary HEALER™ technology enables the pharmaceutical development of Resolvins, overcoming the stability, manufacturing, and formulation hurdles that have limited their commercial development. Thetis is supported by venture capital investors, NIH, and leading private philanthropies, including the Helmsley Charitable Trust, the Crohn’s & Colitis Foundation, and the Kenneth Rainin Foundation.
Disclaimer
TP-317 is an investigational drug product that has not been approved by the U.S. Food and Drug Administration.
Contact Information
For more information, please visit Thetis Pharmaceuticals’ website (www.thetispharma.com) or email us at info@thetispharma.com.