Lipocine NASH prodrug shows liver fat reduction in ongoing study

Lipocine announced top-line interim results from an ongoing study of LPCN 1144, an oral prodrug of bioidentical testosterone designed for the treatment of nonalcoholic steatohepatitis, according to a press release.

“The interim results strongly suggest the potential benefit of LPCN 1144 therapy for patients with [nonalcoholic fatty liver disease] and support further study to validate a histopathologic benefit in patients with NASH,” Stephen A. Harrison, MD, medical director of Pinnacle Clinical Research, San Antonio, said in the release. “Additionally, testosterone therapy has additional known benefits, including improved bone density and muscle mass."

The Liver Fat Study was designed to assess the therapy potential of LPCN 1144 for NASH by evaluating liver fat changes with magnetic resonance imaging-estimated proton density fat fraction

Treatment results at 8 weeks of the 16-week study showed a 7.6% absolute reduction of liver fat and a 38% relative mean liver fat reduction compared with baseline. Regarding responder rates, 86% of patients achieved an absolute liver fat reduction of 4.1% and 71% of patients achieved a reduction of at least 29%.

Based on previous studies with up to 52 weeks of exposure, LPCN 1144 is well-tolerated with no adverse liver enzyme signals or treatment-related severe adverse events or death.

“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,” Mahesh V. Patel, PhD, chairman, president and CEO of Lipocine, said in the release. “We believe LPCN 1144 can offer additional unmet benefits such as improvement in cardiovascular disease, sarcopenia, and sexual dysfunction.”

Reference: www.lipocine.com