Lipocine Reports Positive Topline Phase 2 Results From LPCN 1144 LiFT Study; Stock Rises

Shares of Lipocine Inc. (LPCN) are rising almost 8 percent in Tuesday's pre-market activity after the biopharmaceutical company reported positive topline results from its LiFT Phase 2 clinical study, investigating LPCN 1144 in biopsy-confirmed non-cirrhotic non-alcoholic steatohepatitis or NASH male subjects.

The company noted that both LPCN 1144 treatment arms in the trial met the primary endpoint with statistical significance. Statistically significant reduction in liver fat was observed compared to placebo. Statistically significant reduction in markers of liver injury were also observed compared to placebo.

Currently, there are no approved treatments for NASH, a silent killer that affects about 30 million Americans. LPCN 1144 is an oral prodrug of endogenous testosterone.

In the ongoing randomized, 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, while 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 or MRI-PDFF, and exploratory liver fat/marker end points post 12 weeks of treatment.

Additionally, key secondary endpoints post 36 weeks of treatment include assessment of histological change for NASH resolution and fibrosis improvement as well as liver fat data.

Lipocine noted that treatments with LPCN 1144 post 12 weeks of treatment resulted in robust liver fat reduction, assessed by MRI-PDFF, and showed improvement of liver injury markers with no observed tolerability issues.

Inclusion of d-alpha tocopherol formulated with the testosterone prodrug resulted in additional liver benefits, notably improved key liver markers without compromising tolerability.

The company said it looks forward to sharing 36-week biopsy data from the LiFT study in mid-2021.

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