Incidence of adverse events will form the primary endpoint for the study. Credit: Ulrike Leone from Pixabay.

Clinical-stage biopharmaceutical firm Terns Pharmaceuticals has completed patient enrolment in Phase IIa LIFT study of TERN-101 for treating non-alcoholic steatohepatitis (NASH) patients.

A liver-distributed non-bile acid farnesoid X receptor (FXR) agonist, TERN-101 has shown tolerability profile and enhanced target engagement in the liver.

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The randomised, placebo-controlled clinical trial enrolled 96 patients with phenotypic or biopsy-diagnosed NASH.

They will be given once-daily oral doses of placebo or TERN-101 tablet doses of 5/10/15mg for 12 weeks.

The company noted that TERN-101 plasma concentrations arising from the tablet administration are likely to drop within a comparable range as the plasma concentrations observed in Phase I studies of prior capsule formulation doses of 25 to 150mg.

Incidence of adverse events will form the primary endpoint for the study.

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Key secondary and exploratory outcomes are percent change from baseline in ALT and hepatic fat fraction analysed by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF), key biomarkers linked to histologic improvements in NASH patients.

Terns Pharmaceuticals president and chief medical officer Erin Quirk said: “In all four Phase I clinical trials of TERN-101, none of the 119 subjects who received TERN-101 reported pruritus, and the serum lipid profiles among TERN-101 recipients were similar to placebo recipients even at high doses.

“We believe this favourable tolerability profile stems from the differentiated characteristics of TERN-101, including high liver-distribution, which limits the potential for systemic and intestinal FXR activation.

“We believe this differentiation could give TERN-101 significant advantages over other FXR agonists in development.”

The company began the clinical trial in June last year and anticipates top-line data in the third quarter of this year.

Last year, Terns Pharmaceuticals reported positive results from an ongoing Phase I clinical trial of TERN-201 for the treatment of non-alcoholic steatohepatitis (NASH).