Cirrhosis is an end-stage non-alcoholic fatty liver disease (NAFLD) for which there is no FDA approved drug treatment. During 2015, approximately 1.3M NASH patients had cirrhosis (fibrosis grade 4). NASH cirrhosis patients typically experience increased morbidity and symptoms of hypogonadism such as alteration of hair distribution, anemia, sexual dysfunction, testicular atrophy, muscle wasting, fatigue, osteoporosis, and gynecomastia.

Testosterone levels fall progressively with increased chronic liver disease severity. Low testosterone levels, reported in up to 90% of male cirrhotic patients, is known to increase adverse outcomes and is a predictor of mortality in these patients with increased risk of major infections, transplantation rates, increased risk of for hepatic decompensation, worsening of sarcopenia, and higher Child-Pugh score grade and MELD score. This could also include the severity of portal hypertension and ascites grade.

Our team is currently planning to conduct a Phase 2 proof-of-concept study (NCT 04874350) in male cirrhosis subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhosis subjects.

The planned Phase 2 POC study is a prospective, multi-center, randomized, placebo-controlled study in approximately 48 to 60 male cirrhotic patients that are on the liver transplant list. Subjects will be randomized 1:1 to on of two arms. The treatment arm is an oral dose of a testosterone ester and the second arm is matching placebo. The primary endpoint is change in skeletal muscle index at week 24 with key secondary endpoints including change in liver frailty index and number of waitlist events, including all-cause mortality. Total treatment is expected to be 52 weeks. We currently expect the first subject will be dosed in the fourth quarter of 2021