Thetis Pharmaceuticals has unveiled promising new clinical and preclinical data for TP-317, its novel oral therapy targeting inflammatory bowel disease (IBD), at the 20th Congress of the European Crohn's and Colitis Organization (ECCO) in Berlin.
The Phase 1a clinical trial results mark a significant milestone in the development of TP-317, a first-in-class small molecule drug candidate targeting the BLT1 receptor. The study demonstrated both safety and successful target engagement in healthy volunteers, laying crucial groundwork for further development in IBD treatment.
Safety and Pharmacokinetic Profile
The trial evaluated single ascending doses of TP-317 at 10, 40, and 80 mg, with all doses proving well-tolerated. Notably, no treatment-related adverse events were reported across the dosing range. The drug demonstrated predictable pharmacokinetics, with dose-proportional increases in Resolvin E1 (RvE1) exposure, suggesting reliable oral dosing characteristics.
Target Engagement and Mechanism Validation
"These new data further validate TP-317's unique mechanism of action and its potential as an oral, first-in-class therapy for IBD," stated Gary Mathias, CEO of Thetis Pharmaceuticals. The drug achieved systemic RvE1 levels significantly above the EC50 required for BLT1 activation, confirming successful target engagement.
At the 80 mg dose level, researchers observed transient neutropenia, a known pharmacodynamic effect of RvE1 at BLT1, which resolved within two hours in all subjects. This observation provides additional confirmation of the drug's mechanism of action.
Expert Perspective and Future Development
Dr. Silvio Danese, Gastroenterologist and Professor at Vita-Salute San Raffaele University, emphasized the significance of these findings: "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. This compound presents a unique therapeutic profile distinct from and complementary to current IBD therapies."
Preclinical Evidence Supporting Therapeutic Potential
Accompanying preclinical data highlighted TP-317's comprehensive therapeutic approach, demonstrating gut barrier protection, inflammation reduction, and pain relief properties. These findings support the drug's potential to address multiple aspects of IBD pathology through its novel mechanism of action.
Based on these encouraging results, Thetis Pharmaceuticals plans to advance TP-317 into Phase 1b/2a trials in IBD patients, marking the next crucial step in its clinical development program.
