- Preclinical data shows equivalence of TP-252 and EPA-FFA in modulating inflammatory eicosanoid profiles within the colon
- EPA-FFA has demonstrated clinical efficacy in reducing the rate of relapse in ulcerative colitis
BRANFORD, CT May 8, 2017 – Thetis Pharmaceuticals, a biopharmaceutical company developing novel small molecule drugs for inflammatory bowel disease (IBD), today announced pre-clinical data for its TP-252 candidate. In a study conducted at the Center for Molecular Medicine at UConn Health, TP-252 was shown to produce changes in the profile of bioactive omega-3 and omega-6 metabolites within the colon that were equivalent to eicosapentaenoic acid as the free fatty acid (EPA-FFA), a natural agent with demonstrated clinical efficacy in reducing the rate of relapse in ulcerative colitis (UC) patients.
Bioactive metabolites of omega-3 and omega-6 fatty acids regulate the inflammatory response and have been implicated in UC. Eicosanoids derived from omega-6 fatty acids have been shown to promote inflammation, and are elevated within the colons of UC patients during disease flares. TP-252 treatment in rodents significantly reduced omega-6 metabolites and increased levels of anti-inflammatory omega-3 metabolites.
TP-252 is a derivative of EPA-FFA that Thetis is developing as an adjunct to first-line therapy for the maintenance of remission in UC patients with a history of mild-to-moderate disease.
“There is a significant unmet need for additional oral therapies that can reduce the frequency and severity of UC flares,” said Gary Mathias, Thetis co-founder and Chief Executive Officer. “Based on the clinical efficacy of EPA-FFA itself and the work that Thetis has completed bridging TP-252 to EPA-FFA, we believe TP-252 has prospects to help UC patients maintain remission, improving quality of life and avoiding the need for more aggressive treatments that can have serious risks.”
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.
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.
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).
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Director, Business Development