Lipocine Meets Resolution Regulatory Endpoint In Mid-Stage NASH Trial

Lipocine Inc LPCN has announced topline 36-week results from its Phase 2 proof of concept LiFT study investigating LPCN 1144 in Non-Alcoholic Steatohepatitis (NASH).

• LPCN 1144 comprises an orally delivered prodrug of endogenous testosterone (T).
• At 12 weeks Statistically significant reduction in liver fat was observed compared to placebo (primary endpoint): up to a mean of 9.2% absolute reduction and a 46.8% relative reduction in liver fat. 
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• Both LPCN 1144 treatment arms met with statistical significance the pre-specified accelerated approval regulatory endpoint of NASH resolution with no worsening of fibrosis based on NASH CRN scoring. 
• Additionally, both treatment arms showed substantial improvement of the observed NASH activity in steatosis, inflammation, and ballooning.
• In both treatment arms, substantial and sustained reductions in markers of liver injury compared to placebo were observed.
• During the 36 weeks of treatment, LPCN 1144 was well tolerated with an overall safety profile comparable to placebo. 
• Price Action: LPCN shares are up 1.43% at $1.23 during the premarket session on the last check Wednesday.