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Lipocine Surges On Positive 16-Week Liver Imaging Study For Its NASH Candidate

Shanthi Rexaline

Lipocine Inc (NASDAQ: LPCN) is seeing some momentum Tuesday morning after the company reported results of a study evaluating its non-alcoholic steatohepatitis (NASH) candidate.

What Happened

Lipocine announced top-line results from the 16-week Liver Fat Imaging study of is LPCN 1144, which showed 48 percent of the treated non-alcoholic fatty liver disease, or NAFLD, subjects had NAFLD resolution compared to the 28 percent observed after eight weeks of treatment.

NAFLD resolution is defined as liver fat less than 5 percent post treatment.

All the subjects who experienced NAFLD resolution saw at least a 35 percent relative liver fat reduction from the baseline, with a mean liver fat reduction of 55 percent in the group.

The liver fat study, an open-label, multi-center, single-arm study that evaluated 16-week LPCN 1144 treatment in a cohort of 36 hypogonadal males, was carried out to assess the therapeutic potential of LPCN 1144 in NASH – an advanced form of NAFLD.

The liver fat changes were assessed using magnetic resonance imaging, proton density fat fraction, or MRI-PDFF, technique, which is a non-invasive quantitative biomarker of fat content.

Why It's Important

About 20-30 percent of the U.S. population suffer from NAFLD, and of this 15-20 percent progress to NASH, the company said in the release. NASH can progress to a cirrhotic liver, and eventually hepatocellular carcinoma or liver cancer.

"The results from the Liver Fat Study are striking because both the proportion and degree of improvement in steatosis rivals or exceeds those seen with other drugs currently in development," said Arun Sanyal, Professor in the Virginia Commonwealth University.

Lipocine expects to conduct further clinical testing with LPCN 1144 in biopsy-confirmed NASH subjects.

Lipocine shares traded higher by as much as 22 percent in the pre-market session. At time of publication, the stock traded around $2.38 per share, up 9.5 percent.

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