First-in-human studies targeted for 2019
BRANFORD, CT – (GlobeNewswire – May 23, 2018) – Thetis Pharmaceuticals, a biopharmaceutical company developing novel therapies for treatment of inflammatory bowel disease (IBD), today announced the receipt of a Fast-Track Small Business Innovation Research (SBIR) Grant from the National Institutes of Health (NIH). The award provides up to $1.9 million to support development of Thetis’ TP-252 drug candidate as oral therapy for ulcerative colitis, a chronic, relapsing inflammatory gastrointestinal disorder affecting 800,000 patients in the U.S. and nearly 5 million worldwide.
Gary Mathias, co-founder and Chief Executive Officer, commented: “TP-252 is a novel patented molecule that delivers a natural lipid that has been shown in an independent Phase 2 study to reduce relapse rates and inflammatory biomarkers in ulcerative colitis patients. Based on this compelling clinical proof-of-concept data and the anticipated benign safety profile of our molecule, we are in discussions with potential partners to begin clinical investigation in 2019.”
Dr. Brian E. Harvey, Thetis’ Senior Medical Director and former Director of the Division of Gastroenterology Products at the FDA, commented, “There is a high unmet medical need for safe, oral therapies that can be used with first-line therapy to help patients maintain remission, thereby reducing the need for aggressive immunosuppressive agents. TP-252 offers a benefit-risk profile that is ideally suited for patients with a history of mild-to-moderate disease seeking a safe agent to help reduce the risk of relapse.”
TP-252 is being developed as adjunct therapy to 5-ASA for maintenance of remission in ulcerative colitis patients. This positioning is based on recent clinical evidence from a randomized, placebo-controlled, double-blind Phase 2 trial showing that oral administration of the active moiety in TP-252 significantly reduces the rate of relapse in UC patients already on therapy (see Scaioli et al. 2018). TP-252 has composition of matter patent protection in the U.S., notice of allowance for patent issuance in Europe, and additional applications pending in other major global markets.
Thetis Pharmaceuticals is a biopharmaceutical company developing novel therapies for the treatment of IBD and other inflammatory diseases. Thetis’ proprietary technology platform enables the pharmaceutical development of bioactive lipids that actively regulate inflammation and promote tissue repair and healing. Thetis’s technology overcomes the stability, manufacturing, formulation and patentability hurdles that have limited the development of bioactive lipids as pharmaceutical agents, unlocking their robust pharmacology to be developed as first-in-class therapeutics. During the last 9 months, Thetis has received two Fast Track SBIR awards providing over $4 million to fund development of its unique IBD pipeline.
Thetis is funded by Connecticut Innovations, Inc. and is a member of the Technology Incubation Program at University of Connecticut Health. Preclinical efficacy studies funded under the grant (1R44DK116463) are being conducted in collaboration with Dr. Daniel Rosenberg, Professor of Medicine at the University of Connecticut.
For more information, please visit Thetis’ website (www.thetispharma.com) and follow Thetis on Twitter (@thetispharma).
Director Business Development
The SBIR Award (R44DK116463) is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Statements regarding TP-252 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.