Lipocine Receives FDA Clearance for Testing of NASH Candidate

Lipocine has received clearance from the U.S. Food and Drug Administration (FDA) to clinically investigate LPCN 1144 in an expanded target population of adult male non-alcoholic steatohepatitis (NASH) patients. Specifically, the FDA has waived the limitation of only testing in NASH subjects with total testosterone levels below 300 ng/dL (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 demonstrated meaningful liver fat reductions with good clinical tolerability for chronic use.

NASH is an advanced form of non-alcoholic fatty liver disease (NAFLD) and occurs when fat accumulates in liver cells without excessive alcohol use and a patient has hepatitis (inflammation of the liver) and liver cell damage. Currently, there are no FDA approved treatments for NASH. Approximately 50% of NASH patients are in adult males and the number of NASH cases is projected to increase 63% from 16.5 million cases in 2015 to 27.0 million cases in 2030 (Estes et al. Hepatology, 2018). A recent National Institute of Diabetes and Digestive and Kidney Diseases ("NIDDK") report (Sarkar et al. Gastroenterology 2019) suggests 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; thus, providing a good rationale for testing LPCN 1144 in adult NASH patients regardless of their hypogonadal status.

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

"We are excited about receiving FDA clearance to expand our target patient population in adult NASH males regardless of their hypogonadal status," said Dr. Mahesh Patel, President, Chief Executive Officer and Chairman of the Board of Lipocine. Dr. Patel further stated, "Besides the larger potential market opportunity for LPCN 1144, we believe testing in the expanded cleared patient population will be a pioneering and differentiated potential indication for LPCN 1144."

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