GlobeNewswire·Jul 30, 2026, 7:30 AM ET

Tvardi Therapeutics Selects Ulcerative Colitis as Initial Indication for TTI-109

TVRD

Tvardi Therapeutics selected ulcerative colitis (UC) as the initial disease indication for its next-generation STAT3 inhibitor, TTI-109.
More than 70% of UC patients fail to achieve clinical remission with current therapies targeting individual upstream pathways.
TTI-109 is designed to directly inhibit STAT3, a convergent node downstream of multiple pathways driving immune dysregulation, inflammation, & tissue remodeling.
A completed Phase 1 healthy volunteer study showed placebo-adjusted reductions in immune cell subsets implicated in UC pathology.
The study demonstrated up to 76% reduction in pathogenic Th17-associated subsets, 43% reduction in Tfh subsets, & 71% decline in B cell subsets associated with colonic inflammation.
STAT3 inhibition addresses three interconnected UC drivers, offering a potential solution for patients unresponsive to biologics or JAK inhibitors.
The U.S. UC market represents approximately $3 billion, with a global addressable market of $9 billion for 1.25 million patients.
Current approved therapies achieve less than 30% placebo-adjusted remission rates, often require parenteral administration, & some carry black box warnings for serious adverse events.
TTI-109 is an oral small molecule without a loading dose that achieved over eight-fold greater drug concentration in target tissue compared to plasma in preclinical models.
Over 400 subjects have received Tvardi's STAT3 inhibitors to date, demonstrating a differentiated safety profile from JAK inhibitors.
Tvardi plans to initiate a Phase 2 trial for moderate-to-severe UC in 2027, subject to IND clearance & additional funding, with safety as the primary endpoint.
A Key Opinion Leader webinar featuring Dr. Randy Longman will be hosted on August 19 at 11:00 AM ET to discuss the UC treatment landscape & new TTI-109 data.