Thetis Pharmaceuticals Receives Regulatory Approval in Moldova for Phase 1b Trial of Oral TP-317 in Ulcerative Colitis
ESSEX, Conn. — September 30, 2026 — Thetis Pharmaceuticals, LLC (“Thetis”), a clinical-stage company developing TP-317, a first-in-class, oral BLT1 agonist for inflammatory bowel disease (IBD), today announced that the Medicines and Medical Devices Agency of the Republic of Moldova has approved the conduct of TP317-301, a Phase 1b proof-of-concept trial of oral TP-317 in patients with moderate-to-severe ulcerative colitis.
TP317-301 is a 12-week, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety, tolerability, pharmacokinetics, and efficacy signal of TP-317 in patients with active ulcerative colitis. In addition to clinical, endoscopic, and histopathological response, the trial includes epithelial repair and fibrosis biomarkers as exploratory readouts. The trial is funded by a program-related investment from the Helmsley Charitable Trust.
“Approval in Moldova is an important step toward the first study of TP-317 in patients with ulcerative colitis,” said Gary Mathias, co-founder and CEO of Thetis. “TP-317 provides a non-immunosuppressive mechanism of action that directly promotes epithelial repair to complement the mucosal healing achieved with advanced therapies. This trial is designed to evaluate that mechanism in patients, with endpoints that capture tissue repair and fibrosis in addition to clinical response.”
About Thetis Pharmaceuticals
Thetis is a clinical-stage pharmaceutical company focused on developing new therapies for IBD and oncology. Thetis' lead candidate, TP-317, is a first-in-class, oral Resolvin E1 (RvE1) drug candidate that engages the BLT1 receptor to activate the body’s natural ability to restore tissue and immune homeostasis. In a Phase 1a study, TP-317 was well tolerated and demonstrated target engagement. A Phase 1b proof-of-mechanism trial in moderate-to-severe ulcerative colitis patients will begin recruiting in Q4-2026. Thetis is supported by the Helmsley Charitable Trust, the Crohn's & Colitis Foundation, the Kenneth Rainin Foundation, the National Institutes of Health (NIH), and private investors.
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Tracy Lessor
TLOW Communications
617-519-9827
tracy@tlowcommunications.com