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
ESSEX, CT, USA I February 19, 2025 I Thetis Pharmaceuticals LLC (“Thetis”), 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.
“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.”
The poster presentations include:
Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Oral Resolvin E1-based Therapy in Inflammatory Bowel Disease (IBD): Translating Resolvin E1 Activation of BLT1 in Experimental Models to Healthy Volunteers
Abstract Number: P0627, Abstract Session: Friday, February 21 from 12:40 PM – 1:40 PM CEST (6:40 AM-7:40 AM EST)
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.”
TP-317, a Novel BLT1 Agonist Oral Therapy for Inflammatory Bowel Disease, Exhibits Anti-Inflammatory and Epithelial Barrier Protective Efficacy in Murine DSS Colitis and TNFΔARE Ileitis
Abstract Number: P0069, Abstract Session: Friday, February 21 from 12:40 PM – 1:40 PM CEST (6:40 AM-7:40 AM EST)
This study assessed the efficacy and mechanism of action of TP-317 in preclinical models of colitis. Key findings include:
- 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.
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 candidate that targets the LTB4-BLT1 pathway to mobilize the body’s natural ability to resolve disease and restore immune homeostasis. For more information, please visit www.thetispharma.com, and follow us on LinkedIn.
SOURCE: Thetis Pharmaceuticals
Post Views: 214
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
ESSEX, CT, USA I February 19, 2025 I Thetis Pharmaceuticals LLC (“Thetis”), 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.
“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.”
The poster presentations include:
Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Oral Resolvin E1-based Therapy in Inflammatory Bowel Disease (IBD): Translating Resolvin E1 Activation of BLT1 in Experimental Models to Healthy Volunteers
Abstract Number: P0627, Abstract Session: Friday, February 21 from 12:40 PM – 1:40 PM CEST (6:40 AM-7:40 AM EST)
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.”
TP-317, a Novel BLT1 Agonist Oral Therapy for Inflammatory Bowel Disease, Exhibits Anti-Inflammatory and Epithelial Barrier Protective Efficacy in Murine DSS Colitis and TNFΔARE Ileitis
Abstract Number: P0069, Abstract Session: Friday, February 21 from 12:40 PM – 1:40 PM CEST (6:40 AM-7:40 AM EST)
This study assessed the efficacy and mechanism of action of TP-317 in preclinical models of colitis. Key findings include:
- 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.
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 candidate that targets the LTB4-BLT1 pathway to mobilize the body’s natural ability to resolve disease and restore immune homeostasis. For more information, please visit www.thetispharma.com, and follow us on LinkedIn.
SOURCE: Thetis Pharmaceuticals
Post Views: 214
