HOUSTON, Texas, August 12, 2026
Tvardi Therapeutics, Inc. announced that it will host a key opinion leader (KOL) webinar on August 19, 2026, focused on the clinical potential of its investigational oral small molecule TTI-109 in ulcerative colitis (UC) and the evolving treatment landscape. The webinar will feature Randy Longman, MD, PhD, of Weill Cornell Medicine, alongside Tvardi management. The discussion will examine persistent unmet needs among patients with UC despite advances in currently available treatments, while highlighting new company data and results from the completed Phase 1 healthy volunteer study of TTI-109. Tvardi plans to use the event to discuss the scientific rationale for targeting STAT3, a signaling protein positioned at the intersection of multiple inflammatory pathways implicated in the development and persistence of UC. Management is also expected to outline the company’s planned clinical development strategy for TTI-109 and discuss how a STAT3 inhibitor could potentially fit into future UC treatment approaches.
TTI-109 Targets STAT3 in Ulcerative Colitis
TTI-109 is an investigational oral small molecule designed to target STAT3, a central signaling mediator involved in immune regulation, inflammation and cellular survival. Tvardi believes that STAT3 represents a potentially important therapeutic target because it functions as a convergent node across several biological pathways contributing to inflammatory and proliferative diseases. In UC, abnormal immune activity and persistent intestinal inflammation can contribute to chronic symptoms and tissue damage. By targeting STAT3, Tvardi is investigating whether modulation of this pathway could provide a differentiated treatment approach. The company has completed a Phase 1 healthy volunteer study, with results expected to support further clinical development. However, healthy volunteer data cannot establish whether TTI-109 will be effective in patients with ulcerative colitis. The company will need to demonstrate both an acceptable safety profile and meaningful clinical activity in patient populations before the program can be considered therapeutically validated.
Tvardi Plans UC Patient Study for 2027
Tvardi currently plans to initiate a clinical trial of TTI-109 in patients with moderate-to-severe ulcerative colitis in 2027, subject to FDA clearance of its Investigational New Drug application and availability of additional funding. The planned study is expected to focus primarily on safety, with clinical remission at 12 weeks identified as a secondary endpoint. Exploratory pharmacodynamic assessments are expected to examine serum and tissue biomarkers as well as selected single nucleotide polymorphisms (SNPs). These assessments could help researchers understand whether STAT3 pathway modulation produces measurable biological effects in patients and potentially identify characteristics associated with treatment response. The planned trial remains subject to regulatory and financial conditions, meaning the 2027 timeline is not guaranteed. Additional clinical evidence will be required to establish whether TTI-109 can produce meaningful improvements in patients with moderate-to-severe UC.
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The upcoming KOL webinar will provide an opportunity to place TTI-109 within the broader therapeutic landscape for inflammatory bowel disease. Dr. Randy Longman, a gastroenterologist and mucosal immunologist specializing in inflammatory bowel disease, will provide an independent clinical perspective on the current treatment environment and remaining unmet needs. The event will also include a live question-and-answer session following the presentations. Beyond TTI-109, Tvardi is developing TTI-101, another STAT3-targeting small molecule currently being evaluated in a Phase 1b/2 clinical trial in hepatocellular carcinoma. The company’s broader strategy is focused on developing oral STAT3-targeted therapies for diseases characterized by inflammation, abnormal proliferation and immune dysregulation. The upcoming UC discussion represents an important opportunity to communicate the scientific rationale and development plans for TTI-109, although the program remains in an early stage and its clinical efficacy in UC has yet to be demonstrated.
Source: Tvardi Therapeutics,,press release
