Thetis Pharmaceuticals Awarded Key Patent on HEALER Technology

SOUTHPORT, CT--(Marketwired - Jan 27, 2016) - Thetis Pharmaceuticals LLC, a privately-held biopharmaceutical company focused on gastrointestinal and cardiometabolic diseases, announced today that the USPTO has granted patent US 9,242,008 providing composition of matter protection for two Thetis development candidates, TP-252 for familial adenomatous polyposis and TP-452 for dyslipidemia. The allowed claims include pharmaceutical compositions that are mineral amino-acid based derivatives of fatty acids. National filings outside of the United States are underway.

Frank Sciavolino, Ph.D., co-founder, president and chief scientific officer of Thetis said, "This patent is a cornerstone of our strategy to develop innovative prescription drug products based on small molecule derivatives of fatty acids. The patent further extends our HEALER technology platform, which enables development of eicosanoid-based agents in multiple therapeutic areas. Our agents deliver high plasma levels of fatty acids which are metabolically converted into lipid mediators with potent pharmacology. The industry has been seeking to harness this biology for decades but lipid mediators have proven to be unsuitable for drug development. Our HEALER technology overcomes this hurdle."

About TP-252

TP-252 is focused on treating young patients with familial adenomatous polyposis (FAP) who have intact colons. FAP is a rare genetic disease characterized by the formation of numerous large polyps in the bowel in late childhood or adolescence. Unless these polyps are removed, FAP patients inevitably develop colorectal cancer, typically in their late 30s or early 40s. There are no drugs approved by FDA for the treatment of FAP. Screening, surveillance and prophylactic colectomy constitute the current standard treatment for the management of this disease. Prophylactic surgery, which is usually performed between the ages of 16 and 20 years, carries significant risk of gastrointestinal problems, reproductive issues, and psychosocial burden.

TP-252 is a novel, mineral amino acid-based derivative of eicosapentaenoic acid (EPA) which taken orally delivers high plasma levels of EPA free fatty acid (EPA-FFA). Clinical proof-of-concept demonstrating that EPA-FFA reduces polyp burden in FAP patients has been reported in a Phase II/III randomized, double-blind, placebo-controlled trial completed in 2008 (West et. al. Gut 2010; 59:918-25). Thetis expects to begin clinical trials in 2017 to study TP-252 as adjunct therapy to endoscopic surveillance for the treatment of young FAP patients.

About TP-452

TP-452 is a unique mineral amino acid-based derivative of n-3 docosapentaenoic acid (DPA) which delivers DPA in a highly bioavailable form following oral administration. Preclinical and clinical observations suggest that DPA has significant effects on cholesterol, triglycerides and glucose tolerance. Experimental evidence indicates that DPA affects PCSK9 and HMGCoA reductase, two enzymes involved in cholesterol regulation. Additional data demonstrate that DPA is converted metabolically into lipid mediators, known as T-series resolvins, which exert anti-inflammatory and potent pro-resolving activities in the presence of atorvastatin. Thetis expects to complete ongoing preclinical studies on TP-452 aimed at optimizing its therapeutic credentials in the cardiometabolic arena and anticipates initiating clinical studies in 2017.

About Thetis Pharmaceuticals

Thetis Pharmaceuticals (www.thetispharma.com) is a privately held biopharmaceutical company applying its HEALER™ technology to discover and develop innovative drugs for the treatment of gastrointestinal and cardiometabolic diseases. Using the HEALER platform, Thetis transforms fatty acids into small molecule pharmaceuticals as stable, solid free flowing API, with composition of matter patent protection. Thetis is implementing this approach to capitalize on the innate pharmacology of these bioactive lipids to develop a robust pipeline of new medicines addressing unmet medical needs in the gastrointestinal and metabolic disease areas.