Lipocine announces positive results for LPCN 1144 treatment in NASH

Lipocine announced positive results from its phase 2 proof of concept study that investigated LPCN 1144, an orally delivered prodrug of endogenous testosterone, in the treatment of nonalcoholic steatohepatitis, according to a press release.

The Liver Fat intervention with oral Testosterone (LiFT) clinical study comprised 37 men with NASH dosed twice daily with either 142 mg testosterone equivalent (n = 13), 142 mg testosterone equivalent formulated with 238 mg of d-alpha tocopherol equivalent (n = 13) or matching placebo (n = 11). Studied endpoints included change in hepatic fat fraction after 12 weeks of treatment as well as histological change for NASH resolution and/or fibrosis improvement after 36 weeks of treatment. Researchers performed liver biopsies at baseline and following 36 weeks of treatment.

At 12 weeks, study results demonstrated a mean 9.2% absolute reduction in liver fat and a 46.8% relative reduction in liver fat compared with placebo. Further, both LPCN 1144 treatment groups showed improvement in NASH with no worsening of fibrosis responders compared with placebo (60% and 57% vs. 13%, respectively). During 36 weeks of treatment, LPCN 1144 was well tolerated with a safety profile comparable with placebo.

“The extent of the LPCN 1144 efficacy results in meeting the NASH resolution regulatory endpoint from the LiFT study are striking with no adverse safety signal,” Arun Sanyal, MD, professor at the Virginia Commonwealth University department of internal medicine and education core director at the VCU Center for Clinical and Translational Research, said in a press release. “These data strongly support further development of this differentiated novel approach as a treatment of NASH.”