Tvardi Therapeutics has dosed the first patients in each arm of its Phase II REVERT Liver Cancer trial of TTI-101 to treat locally advanced or metastatic, and unresectable hepatocellular carcinoma (HCC).

The ongoing study is assessing the clinical activity and safety of TTI-101 alone and along with standard of care therapy in HCC patients.

It is currently enrolling patients from top cancer research institutes in the US.

TTI-101 as a monotherapy is evaluated in patients who were previously treated with up to three lines of systemic therapy.

In combination therapy, TTI-101 is assessed along with pembrolizumab (Keytruda) in patients previously treated with immunotherapy, and with atezolizumab (Tecentriq) and bevacizumab (Avastin) in treatment naïve patients.

Tvardi Therapeutics CEO Imran Alibhai said: “Enthusiasm for our HCC study continues to expand with recently presented clinical data demonstrating TTI-101 monotherapy has robust efficacy in heavily pretreated patients with HCC, published preclinical work highlighting TTI-101’s synergy with immunotherapy, and the FDA’s Fast-Track Designation for TTI-101 in HCC.

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“This is the second of three Phase II trials Tvardi has initiated to address diseases driven by STAT3.”

Tvardi is also evaluating TTI-101 in patients with idiopathic pulmonary fibrosis and metastatic breast cancer in Phase II clinical programmes.

TTI-101 is an orally delivered, small molecule, direct inhibitor of STAT3, a key regulatory protein responsible for the pathogenesis of HCC.

Patient enrolment in a TTI-101 Phase I trial has been completed. TTI-101 was well-tolerated as a monotherapy and showed multiple durable radiographic objective responses.