Tvardi Therapeutics: TTI-109 Delivers on Healthy Volunteer Objectives; Clinical Proof Is Next Key Test

Research evidence excerpt

Tvardi Therapeutics: TTI-109 Delivers on Healthy Volunteer Objectives; Clinical Proof Is Next Key Test

Barclays | Tvardi Therapeutics

remains an open question. As such, while the shorter duration of diarrhea observed with

TTI‑109 is a positive signal, it remains unclear whether GI tox could emerge with longer

treatment durations or in combination settings.

IND expected by year-end; Phase 2 initiation targeted for 1H27

With Phase 1 now complete and the nine-month NHP toxicology program finished,

management stated that no additional preclinical work is required before entering patient

studies. The company expects to complete the clinical study report over the coming months

and expects to submit an IND by the end of 2026. Depending on financing, management

indicated that Phase 2 studies could begin in 1H27, with interim biopsy-based proof-of-concept

data potentially available in 1H28 and fuller clinical datasets thereafter.

Lead indication selection remains ongoing. Potential areas under consideration span both

dermatology and GI diseases, including indications such as hidradenitis suppurativa,

dermatomyositis, Crohn's disease, ulcerative colitis, and fibrosis-associated diseases.

Management emphasized a preference for indications that combine immune dysregulation,

inflammation, and proliferative tissue remodeling, arguing that these settings may be

particularly well suited for STAT3 inhibition.

Importantly, these future patient studies will represent the first opportunity to determine

whether the immune modulation observed in healthy volunteers translates into meaningful

activity in disease settings. Management emphasized the ability to obtain biopsies in many

targeted dermatology and GI indications, which could provide an earlier assessment of