Lipocine fatty liver therapy leads to high rates of NAFLD resolution

LPCN 1144 significantly reduced liver fat in patients with nonalcoholic fatty liver disease after 16 weeks, according to a press release from the manufacturer, Lipocine.

“We are encouraged by the Liver Fat Study results, especially the extent of the observed NAFLD resolution which improved over eight-week interim results with potential for further improvement upon longer treatment,” Mahesh V. Patel, PhD, chairman, president and CEO of Lipocine, said in the release. “We look forward to conducting further clinical testing with LPCN 1144, in biopsy confirmed NASH subjects.”

The Liver Fat Study comprised 36 hypogonadal men. Of the 34 patients with at least one MRI-PDFF visit after baseline enrollment, 62% had NAFLD with a baseline liver fat of at least 5%.

At 16 weeks, 48% of patients who received LCPN 1144 had NAFLD resolution with an average liver fat improvement of 28% after approximately 8 weeks.

Additionally, all patients who experienced NAFLD resolution had at least a 35% relative liver fat reduction from baseline with a relative mean liver fat reduction of 55%.

LPCN was well-tolerated during the study.

“The results from the Liver Fat Study are striking because both the proportion and degree of improvement in steatosis rivals or exceeds those seen with other drugs currently in development,” Arun Sanyal, MD, from the Virginia Commonwealth University, said in the release. “Furthermore, the extent of NAFLD resolution provides a strong rationale for additional studies in both hypogonadal males with NASH as well as more unselected populations of men with NASH.”

Reference: www.lipocine.com