Thetis Awarded $1.9M NIH Grant to Advance TP-252 into Clinical Trials for Ulcerative Colitis

Thetis Awarded $1.9M NIH Grant to Advance TP-252 into Clinical Trials for Ulcerative Colitis

Thetis Pharmaceuticals recently received a $1.9 million fast-track Small Business Innovation Research grant from the National Institutes of Health (NIH) to help advance the development of TP-252, an investigational oral therapy for ulcerative colitis (UC), into clinical trials.

TP-252 is a derivative of eicosapentaenoic acid free fatty acid (EPA-FFA), which has been shown to help reduce relapse in UC patients. EPA-FFA is naturally found in the human body and plays a critical role in the regulation of the body’s inflammatory response.

TP-252 is being developed as an adjunct therapy to 5-ASA, or mesalimine, a therapy used in the maintenance and remission of UC.  5-ASA is approved by the U.S. Food and Drug Administration for UC treatment.

As an add-on therapy to first-line treatment 5-ASA, TP-252 could be beneficial to UC patients by controlling the underlying inflammation and reducing the frequency and severity of disease relapses, reducing the need for more aggressive therapies and decreasing the risk of severe adverse reactions.

TP-252’s active compound was recently investigated in a randomized, placebo-controlled, double-blind trial (NCT02179372) in which it was shown to significantly reduce the rate of relapse of UC patients already on therapy.

“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,” Gary Mathias, Thetis’ co-founder and CEO, said in a press release.

The grant allows the company to start preparing the launch of the first-in-human studies for TP-252, planned for 2019.

“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,” said Brian E. Harvey, MD, PhD, Thetis’ senior medical director.

UC is a form of inflammatory bowel disease estimated to affect 800,000 patients in the U.S. and nearly 5 million worldwide, according to Thetis.