Lipocine announced Thursday that eight-week top-line, interim results from an ongoing 16-week liver fat imaging study of LPCN 1144 showed an absolute mean reduction from the baseline of 7. 6-percent liver fat and a 38-percent relative mean liver fat reduction from baseline.
LPCN 1144 is an oral prodrug of bioidentical testosterone.
Also, the company said there was an 86-percent responder rate in which subjects experienced at least a 4.1-percent absolute reduction in liver fat from baseline and a 71-percent responder rate in which subjects experienced at least a 29-percent reduction in liver fat from baseline.
The liver fat study is an open-label, multicenter, single arm study that is evaluating LPCN 1144 in a cohort of hypogonadal males, according to Lipocine.
The interim results are based on seven of the nine subjects with baseline liver fat of at least 10 percent.
Liver fat changes were assessed using magnetic resonance imaging and proton density fat fraction, a non-invasive quantitative biomarker of liver fat content.
Why It's Important
NASH affects about 30 million Americans and has no approved treatment.
"We are very encouraged by these results especially as the observed liver fat reductions are the largest of any well-tolerated oral product candidate within approximately eight weeks," Lipocine CEO Mahesh Patel said in a statement.
"We believe LPCN 1144 can offer additional unmet benefits such as improvement in cardiovascular disease, sarcopenia and sexual dysfunction."
The company said it will present the 16-week results later this quarter.
Lipocine shares were soaring more than 44 percent to $2.29 at the time of publication Thursday.
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