LPCN - Lipocine announces positive results from phase 2biopsy-confirmed NASH study

Clinical-stage biopharmaceutical company Lipocine (LPCN) announces that its treatment for biopsy-confirmed non-cirrhotic non-alcoholic steatohepatitis ((NASH)) in male patients, showed statistically significant reduction in liver fat compared to placebo as part of a phase 2 trial.In the double-blind, placebo-controlled 36-week treatment LiFT study, subjects with F1-F3 fibrosis were randomized 1:1:1 to one of three arms; Treatment A is a twice daily oral dose of 142 mg testosterone equivalent; Treatment B is a twice daily oral dose of 142 mg testosterone equivalent formulated with 217 mg of d-alpha tocopherol equivalent; and the third arm is twice daily matching placebo.The primary endpoint is change in hepatic fat fraction via Magnetic Resonance Imaging Proton Density Fat Fraction ("MRI-PDFF") and exploratory liver fat/marker end points post 12 weeks of treatment.Three subjects in the placebo group and one subject in the combined treatment arms discontinued study drug due to Treatment Emergent Adverse Events ((TEAEs)).The company expects to share 36-week biopsy data

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Lipocine announces positive results from phase 2biopsy-confirmed NASH study