– Lead candidate TP-252 expected to begin clinical studies in 2018
BRANFORD, CT– (May 5, 2017) – Thetis Pharmaceuticals LLC (“Thetis”), a biopharmaceutical company developing small molecule drugs for treatment of gastrointestinal diseases, announced two development candidates, TP-252 and TP-317, for treatment of inflammatory bowel disease (IBD).
Gary Mathias, co-founder and chief executive officer, commented, “In contrast to existing therapies that work by inhibiting the inflammatory response, our agents offer an immuno-resolving approach to IBD treatment based on limiting inflammation and promoting tissue repair and healing, without suppressing normal immune function.”
Dr. Frank Sciavolino, co-founder and chief scientific officer, commented “Our agents deliver endogenous bioactive lipids that play a critical role in regulating the inflammatory immune response. Our proprietary technology platform unlocks the potent pharmacology of these lipids for treatment of IBD.”
IBD is a collection of chronic relapsing inflammatory disorders of the gastrointestinal (GI) tract characterized by recurrent flares that cause abdominal pain, diarrhea, and bleeding. The most common forms of IBD are ulcerative colitis, which affects the colon and rectum, and Crohn’s disease, which may affect any part of the GI tract but commonly manifests in the small and large bowel. The goal of IBD medical therapy is to control inflammation, thereby decreasing the frequency and severity of disease flares.
Existing IBD therapies work by blocking or inhibiting key steps in the immunological processes that constitute the inflammatory response, which may lead to undesirable side effects. As a result, many product labels for IBD drugs have black box warnings for increased risk of serious infections and malignancies. Moreover, up to 50% of patients treated with current therapies are non-responsive or experience relapse within 12 months of a prior flare. Thus, there is a clear need for additional therapeutic options.
TP-252 is a derivative of eicosapentaenoic acid free fatty acid (EPA-FFA). EPA-FFA itself has been shown in an independent, 6-month clinical trial to significantly reduce the number of UC patients who experienced a flare. Thetis expects to begin TP-252 clinical trials in 2018, targeting an indication as adjunct oral therapy to 5-ASAs for the maintenance of remission in UC patients with a history of mild to moderate disease. TP-252 has the potential to safely extend the maintenance of remission, thereby delaying the need for UC patients to be escalated to biologics and other immunosuppressive agents.
TP-317 is a unique derivative of a newly discovered class of bioactive lipids known as Specialized Pro-Resolving Mediators (SPMs). SPMs are endogenous lipid mediators that have been shown pre-clinically to control gastrointestinal inflammation and gut mucosal immune responses at very small doses. These data suggest multiple effects directly relevant to treatment of IBD, including down-regulation of pro-inflammatory signals, reduced penetration of bacteria into the intestinal wall, and promotion of tissue repair and healing. TP-317 has the potential to be a non-immunosuppressive alternative or complement to biologics for treatment of IBD. TP-317 is undergoing pre-clinical studies.
About Thetis Pharmaceuticals
Thetis Pharmaceuticals is a biopharmaceutical company developing small molecule drugs for the treatment of IBD. The Thetis approach is based on leveraging the known immuno-resolving pharmacology of bioactive lipids with its proprietary technology platform to overcome the intellectual property, manufacturing and formulation hurdles that have limited their development as pharmaceutical agents. Thetis applies this proprietary technology, called HEALER™ (High Efficiency Amino Lipid Enabled Release), to bioactive lipids that have been shown to dampen inflammation and promote gut mucosal tissue repair and healing.
For more information, please visit Thetis Pharmaceuticals’ website at www.thetispharma.com and follow Thetis on Twitter (@thetispharma).
Director, Business Development