Thetis Forms Australia Subsidiary to Investigate First-in-Class Oral Resolvin E1 Drug (TP-317) for Moderate-to-Severe IBD
Essex, CT – (June 13, 2023) – Thetis Pharmaceuticals LLC (“Thetis”), a biopharmaceutical company developing a first-in-class, oral small molecule Resolvin E1-based drug to treat cancer and chronic inflammatory diseases, today announced today the formation of Thetis Pharma Pty Ltd. in Australia to conduct a single ascending dose Phase 1a trial of oral TP-317 in healthy subjects.
Gary Mathias, Chief Executive Officer of Thetis, commented, “The clinical trial will investigate the safety, tolerability, and pharmacokinetics of our oral Resolvin E1 (RvE1) drug, TP-317, in healthy subjects. Thetis has developed a proprietary enteric-coated tablet that opens the door to clinical investigation of RvE1 in inflammatory bowel disease (IBD), other autoimmune diseases, and cancer. This advance is the first time in history that a Resolvin drug has been formulated as a conventional tablet for clinical studies. Our Australian subsidiary plans to file a Clinical Trial Notification later this year to begin enrolling subjects in early 2024. “
About TP-317
Overview: TP-317 is a patented small molecule drug that delivers Resolvin E1, an endogenous lipid mediator that engages BLT1 as a biased agonist to promote 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 moderate-to-severe Crohn’s disease and as second-line, oral therapy for moderate-to-severe ulcerative colitis in patients who are not well controlled on existing therapies. The anticipated high safety premium and unique epithelial repair mechanism of TP-317 supports its use as adjunct therapy to standard-of-care biologics and oral immunomodulators.
Cancer Program: TP-317 is being developed in cancer as an adjunct to standard of care therapy in advanced colorectal cancer and advanced non-small-cell lung cancer (NSCLC). Its unique myeloid-directed antigen presentation mechanism of action addresses a fundamental need in immunotherapy. 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, chemotherapy and their combination.
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
Gary Mathias, CEO
gmathias@thetispharma.com