Thetis Announces $3 Million SBIR Grant from the NIH to Develop Oral Therapy for Mild-to-Moderate IBD (3/15/23)
Essex, CT – (March 15, 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, announced today the receipt of a Fast-Track Small Business Innovation Research (SBIR) Grant from the National Institute of Health (NIH). The total SBIR award provides up to $3 million to support development of Thetis’ Resolvin-E1 based drug (TP-317) for treatment of inflammatory bowel disease (IBD).
Gary Mathias, Chief Executive Officer of Thetis, commented, “The NIH grant will support our TP-317 program targeting mild-to-moderate ulcerative colitis and Crohn’s disease, which are chronic inflammatory disorders of the gastrointestinal tract that affect 3 million people in the U.S. with an addressable market projected to reach $28 billion by 2028.”
John Parkinson, PhD, Thetis’ Chief Scientific Officer, added, “Current therapies for these diseases are inadequate. There is no safe, oral agent approved as first-line therapy for Crohn’s disease, and 5-ASA therapy, which is approved as first-line therapy for ulcerative colitis, fails to maintain remission in 50% of patients within 12 months of starting treatment. As a result, many patients are escalated to immuno-suppressive drugs such as biologics and immunomodulators, which are incompletely effective, increase risk of serious infection and cancer, and have side effects that reduce compliance and quality of life. In addition, injectable biologics are expensive, inconvenient, and can lose efficacy over time.”
About TP-317
TP-317 is a patent-protected small molecule drug that delivers Resolvin E1 (RvE1), an endogenous lipid mediator that restores 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: In inflammatory bowel disease, oral TP-317 is being developed as a first-line therapy for mild-to-moderate Crohn’s disease and as second-line therapy for mild-to-moderate ulcerative colitis patients who are not well controlled on 5-ASA or corticosteroids. In colitis models, oral TP-317 dosed once daily has shown efficacy in DSS, TNBS, TNFΔARE and T-cell transfer colitis models. In DSS-induced colitis, TP-317 has shown comparable efficacy to 5-ASA and the JAK inhibitor filgotinib and enhanced efficacy when combined with 5-ASA.
Cancer Program: In cancer, TP-317 is being developed as an adjunct to immune checkpoint inhibitors in refractory metastatic melanoma and advanced non-small cell lung cancer (NSCLC), and as adjunct to chemotherapy in pancreatic cancer. TP-317 has demonstrated potent single agent activity in melanoma, lung and pancreatic cancer tumor models, and enhanced efficacy when combined with immune checkpoint inhibitors or chemotherapy in “immune cold” and immune-responsive tumors.
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. The SBIR Award (R44DK116460) is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). Statements regarding TP-317 and the SBIR Award are solely the responsibility of Thetis Pharmaceuticals LLC and do not represent the official views of the NIH.
Contact Information
For more information, please visit Thetis Pharmaceuticals’ website (www.thetispharma.com) or email us at info@thetispharma.com