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.
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.
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).