Thetis Pharmaceuticals Presents New Preclinical and Clinical Data for TP-317 at ECCO 2025
Thetis Pharmaceuticals Presents New Preclinical and Clinical Data for TP-317 at ECCO 2025
Thetis Pharmaceuticals LLC, a clinical-stage company developing TP-317, a first-in-class, small molecule drug candidate targeting the BLT1 receptor to treat inflammatory bowel disease (IBD), Crohn’s disease and ulcerative colitis, today announced the presentation of new preclinical and clinical data at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO) in Berlin, Germany, February 19-22, 2025.
Phase 1a Clinical Results Demonstrate a Favorable Safety Profile and BLT1 Engagement In Healthy Volunteers. Preclinical Data Highlight TP-317’s Anti-Inflammatory, Epithelial Barrier-Protective Effects.
“These new data further validate TP-317’s unique mechanism of action and its potential as an oral, first-in-class therapy for IBD,” said Gary Mathias, CEO of Thetis Pharmaceuticals. “The preclinical results demonstrate gut barrier protection, inflammation reduction, and pain relief, while our clinical data confirm safety, predictable PK, and BLT1 engagement in humans. We’re excited to advance TP-317 into Phase 1b/2a trials in IBD patients.”
This Phase 1a clinical trial evaluated the pharmacokinetics, pharmacodynamics, and safety profile of oral TP-317 in healthy volunteers. Key findings include:
• Single ascending doses (10, 40, and 80 mg) of TP-317 were well tolerated, with no treatment-related adverse events.
• TP-317 achieved systemic Resolvin E1 (RvE1) levels well above the EC50 for BLT1 activation, confirming target engagement.
• At the 80 mg dose, transient neutropenia (a known pharmacodynamic effect of RvE1 at BLT1) was observed but quickly rebounded within two hours in all subjects.
• PK analysis showed dose-proportional increases in RvE1 exposure, supporting a predictable oral dosing profile.
“The data from this first-in-human study provide support for target engagement by TP-317 in humans and establish a strong foundation for further clinical development in ulcerative colitis and Crohn’s disease,” said Silvio Danese, M.D., Ph.D., Gastroenterologist and Professor of Gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan. “This compound presents a unique therapeutic profile distinct from and complementary to current IBD therapies.”
In a two-cycle DSS colitis model, oral TP-317 treatment significantly reduced disease activity index (DAI) scores, histologic inflammation, and crypt damage, demonstrating strong anti-inflammatory and mucosal barrier-protective effects. In TNFΔARE ileitis models, TP-317 lowered intestinal permeability and reduced pro-inflammatory cytokines, reinforcing its potential as a disease-modifying therapy for Crohn’s disease and ulcerative colitis. In a visceral pain study, TP-317 reduced pain responses to colorectal distension to levels comparable to prednisolone, suggesting potential benefits for IBD-associated abdominal pain.
“These findings highlight TP-317’s ability to restore gut barrier integrity, suppress inflammation, and alleviate visceral pain, reinforcing its promise as a novel oral therapy for both ileal and colonic forms of IBD,” said Bram Verstockt, M.D., Ph.D., Consultant Gastroenterologist IBD, University Hospitals Leuven, Belgium.
