Thetis Pharmaceuticals Announces Positive Initial Results From Phase 1a Study of TP-317 in Healthy Subjects

TP-317, an Oral BLT1 Agonist, was Well Tolerated, Showed a Favorable Safety Profile, and Demonstrated Target Engagement

A Phase 1b Study of TP-317 in Ulcerative Colitis Patients is Planned for 2025

ESSEX, Conn.--(BUSINESS WIRE)--Thetis Pharmaceuticals, LLC (“Thetis”), a clinical-stage company developing TP-317, an oral small molecule therapy based on Resolvin E1 (RvE1) for the treatment of inflammatory bowel disease (IBD) and cancer, today announced positive top-line results from its Phase 1a study of TP-317 in healthy subjects. The study showed that TP-317 was safe and well tolerated, with pharmacokinetics that support dose selection for a follow-on Phase 1b trial in ulcerative colitis patients. Full results will be presented at a medical conference in 2025.

“This is an important milestone for the development of TP-317 and our mission to develop therapies that harness the body’s ability to resolve disease and promote immune homeostasis,” said Gary Mathias, co-founder and CEO of Thetis. “We believe TP-317’s novel BLT1 receptor agonist mechanism offers significant potential for addressing unmet needs in IBD and solid tumor cancers.”

The randomized, single-blind, placebo-controlled, single ascending dose study enrolled 24 healthy subjects. Fasted participants received a single oral dose of TP-317 or placebo in a 3:1 ratio at three dose levels: 10 mg, 40 mg, and 80 mg. The study met its primary endpoints of safety and tolerability, and its secondary pharmacokinetic endpoint. The study also demonstrated target engagement based on an exploratory endpoint associated with RvE1 activation of BLT1.

A Phase 1b study in ulcerative colitis (UC) is planned for 2025 that will further evaluate safety and pharmacokinetics, with exploratory endpoints including clinical and endoscopic response, clinical remission, and biomarker analysis.

About Thetis Pharmaceuticals

Thetis is a clinical-stage pharmaceutical company focused on developing innovative treatments for chronic inflammatory diseases and cancer. Its lead candidate, TP-317, is a first-in-class oral RvE1 drug that targets the LTB4-BLT1 pathway to mobilize the body’s natural ability to resolve disease and restore immune homeostasis. Thetis is backed by private investors, the National Institutes of Health (NIH), and prominent philanthropic organizations such as the Helmsley Charitable Trust, Crohn's & Colitis Foundation, and Kenneth Rainin Foundation. For more information, please visit www.thetispharma.com, and follow us on LinkedIn.