NASH Candidate Cleared for Testing in Expanded Target Population

Cases Projected to Increase From 16.5 Million to 27.0 Million by 2030

Lipocine, Inc. has received clearance from the FDA to clinically investigate LPCN 1144 in an expanded target population of adult male patients with non-alcoholic steatohepatitis (NASH). Specifically, the agency has waived the limitation of only testing in NASH subjects who have total testosterone levels < 300 ng/dL (the threshold for hypogonadism). 

LPCN 1144 is a differentiated oral treatment with a postulated multi-dimensional mechanism of action across the full NASH disease spectrum and has shown meaningful reductions in liver fat with good clinical tolerability for chronic use.  

Non-alcoholic steatohepatitis is an advanced form of non-alcoholic fatty liver disease (NAFLD) that occurs when fat accumulates in liver cells without excessive alcohol use and a patient has hepatitis and liver cell damage. Currently, there are no approved treatments for the disease. 

Approximately 50% of patients with NASH are adult males and the number of cases is projected to increase from 16.5 million cases in 2015 to 27.0 million cases by 2030. Recently, a report in Gastroenterology suggested that 75% of biopsy-confirmed NASH subjects have less than 372 ng/dL of total testosterone and that the degree of fibrosis severity is inversely related to free testosterone levels. This provides a good rationale for testing LPCN 1144 in adult patients with NASH, regardless of their hypogonadal status.

LPCN 1144 is being studied in the LiFT (Liver Fat intervention with oral Testosterone) phase 2 clinical study, a paired-biopsy study in subjects with confirmed pre-cirrhotic NASH. LiFT is a prospective, multi-center, randomized, placebo-controlled multiple-arm study in male subjects with biopsy-confirmed NASH who have grade F2/F3 fibrosis and a NAFLD Activity Score (NAS) ≥ 4 with a 36-week treatment period.  

Source: Seeking Alpha, July 23, 2019