BRANFORD, CT / ACCESSWIRE / October 24, 2019 / Thetis Pharmaceuticals, a biopharmaceutical company developing novel therapies for treatment of gastrointestinal diseases, today announced the receipt of a Fast-Track Small Business Innovation Research (SBIR) Grant from the National Institutes of Health (NIH) for development of an innovative new therapy (TP-352) for non-alcoholic steatohepatitis (NASH), a chronic fatty liver disorder affecting 18 million patients in the U.S. The grant provides up to $2.3 million for preclinical studies that are expected to fully support submission of an investigational new drug application in 2020.
Dr. Anna Mae Diehl, a leading NASH researcher who is the Director of the Liver Center at Duke University School of Medicine and a clinical advisor to Thetis, commented, "NASH is a major public health issue with no FDA-approved treatment. NASH is one of the leading causes of end-stage liver disease, hepatocellular carcinoma, and liver transplantation. There is a significant unmet need for safe, oral therapies for treatment of NASH."
"TP-352 is a promising approach to treating NASH given the established efficacy and safety of its active moiety, DHA [docosahexaenoic acid]," commented Dr. Brian E. Harvey, Thetis' Senior Regulatory Director and former Division Director of Gastroenterology Products at the Food and Drug Administration. "In multiple clinical studies DHA treatment was associated with improvements in key aspects of NASH pathology. Based on its multifaceted mechanism of action and anticipated safety, we see an opportunity for TP-352 to become a cornerstone therapy in NASH, both as monotherapy and as part of combination approaches."
"With this grant funding, Thetis has raised $7 million of non-dilutive NIH grant funding across our portfolio of gastrointestinal drug candidates," stated Gary Mathias, Thetis' CEO. "We are poised to rapidly advance TP-352 in NASH and our TP-317 candidate in IBD into clinical investigation."
TP-352 is a potential first-in-class therapy based on DHA, an omega-3 fatty acid with clinical proof of concept in NASH. Recent findings suggest that DHA has unique pharmacological activity in NASH compared to eicosapentaenoic acid (EPA), which is the principal moiety in the currently approved omega-3 based drugs that include Lovaza, Vascepa and Epanova. These data suggest that a DHA drug product could provide a novel, first-in-class therapeutic approach to treating NASH. Developed using Thetis' proprietary HEALER™ chemistry platform, TP-352 is a new molecule that delivers DHA with superior bioavailability compared to DHA as the natural oil, enhanced stability and formulation properties, and composition of matter patent protection in the U.S. and Europe. Thus, TP-352 has the key credentials necessary to translate the robust pharmacology of DHA into a pharmaceutical drug for treatment of NASH.
Thetis Pharmaceuticals is a biopharmaceutical company developing novel therapies for the treatment of gastrointestinal diseases. Thetis' proprietary HEALER™ technology platform enables the pharmaceutical development of bioactive lipids, including omega-3 fatty acids and specialized pro-resolving lipid mediators, that actively regulate inflammation resolution and tissue repair. Thetis' HEALER™ technology overcomes the stability, manufacturing, formulation and patentability hurdles that have limited the development of bioactive lipids as pharmaceutical agents, thus unlocking their robust pharmacology to be developed as first-in-class drugs.
For more information, please visit Thetis' website (www.thetispharma.com) and follow Thetis on Twitter (@thetispharma).
Director Business Development
The SBIR Award (1R44DK121612) is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Statements regarding TP-352 and the SBIR Award are solely the responsibility of Thetis Pharmaceuticals LLC and do not represent the official views of the National Institutes of Health.
SOURCE: Thetis Pharmaceuticals