Tvardi selects ulcerative colitis as first indication for TTI-109, sets KOL webinar

Tvardi Therapeutics said on July 30, 2026 that it has chosen ulcerative colitis (UC) as the first disease target for its next generation STAT3 inhibitor, TTI-109. The selection follows completion of the TTI-109 Phase 1 healthy volunteer study, which demonstrated placebo-adjusted reductions across cellular and humoral immune cell subsets implicated in UC pathology.¹

In that study, TTI-109 modulated multiple STAT3-driven immune cell populations, including Th17, T follicular helper (Tfh) and B cells, cell types known to expand with UC disease severity and infiltrate the inflamed colon.¹ Further breakdown across the active dose range showed broad suppression of pathogenic Th17-associated immune populations, including up to 76% reduction in subsets associated with mucosal destruction and treatment-refractory UC, up to 43% reduction in Tfh subsets tied to disease activity, and up to 71% decline in B cell subsets associated with colonic inflammation.¹

The company frames UC as a substantial commercial opportunity: more than 1.25 million patients are diagnosed with UC in the United States, representing what Tvardi estimates as an addressable market of approximately $3 billion in the U.S. and $9 billion globally.¹ Tvardi also said that currently approved therapies, including anti-TNF, anti-integrin, anti-IL-12/23, S1P and JAK inhibitors, achieve placebo-adjusted clinical remission rates below 30%, and most are administered parenterally.¹ It added that JAK inhibitors carry a black box warning for major adverse cardiovascular events, mortality, thrombosis, serious infections and malignancy.¹

Tvardi plans to initiate a study of TTI-109 in patients with moderate-to-severe UC in 2027, subject to IND clearance and additional funding, with safety as the primary endpoint and clinical remission at 12 weeks as the secondary endpoint.¹

Tvardi will host a Key Opinion Leader webinar on August 19 at 11:00 a.m. ET featuring Dr. Randy Longman of Weill Cornell Medicine, during which management will present new TTI-109 data and Longman will discuss the evolving UC treatment landscape and unmet needs.¹