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Lipocine rallies after therapy candidate achieves meaningful liver fat reduction

The drug targets non-alcoholic steatohepatitis, which according to Lipocine affects 30 million Americans
The therapy candidate LPCN 1144 is being tested with 36 males

Lipocine Inc (NASDAQ:LPCN) surged Thursday after reporting that interim results showed its therapy candidate for non-alcoholic steatohepatitis (NASH) achieved meaningful liver fat reduction.

The specialty drug company announced the interim results after about eight weeks of an ongoing 16-week study of LPCN 1144. The therapy candidate produced an absolute mean reduction from baseline of 7.6% liver fat and a 38% relative mean liver fat reduction, according to Lipocine.

Shares of Salt Lake City-based Lipocine rose $0.39, or 25%, to $1.99 in Thursday’s Nasdaq trading.

READ: Lipocine's LPCN 1111 Phase 2b clinical study kicks off

The company said there was an 86% responder rate in which subjects experienced at least a 4.1% absolute reduction in liver fat from baseline and a 71% responder rate in which subjects experienced at least a 29% reduction in liver fat from baseline.

The ongoing liver fat study is an open-label, multi-center, single-arm study evaluating the treatment of 36 hypogonadal males, lacking sufficient testosterone or having an impaired ability to produce sperm.

Non-alcoholic steatohepatitis is an advanced form of non-alcoholic fatty liver disease that occurs when fat accumulates in liver cells from causes other than excessive alcohol use. Patients have hepatitis (inflammation of the liver) and liver cell damage.

CEO encouraged by results

"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,” Dr Mahesh Patel, the chairman, president and CEO of Lipocine, said in a statement. “We look forward to the 16-week results later this quarter."

He added that he believes LPCN 1144 can offer additional unmet benefits such as improvement for patients with cardiovascular disease, sarcopenia and sexual dysfunction.

There are no approved treatments of NASH, according to Lipocine, which says the illness is a silent killer that affects 30 million Americans.

Contact Dennis Fitzgerald at [email protected]

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