Business
Lipocine Completes Enrollment of LPCN 1148 Phase 2 Study for Decompensated Cirrhosis
Top-line 24-week results from proof-of-concept study expected mid-2023 SALT LAKE CITY, Dec. 19, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a
About this update from Lipocine Inc.
[{"type":"text","content":"Top-line 24-week results from proof-of-concept study expected mid-2023\nSALT LAKE CITY, Dec. 19, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (\"CNS\") disorders by leveraging its proprietary platform to develop differentiated products, today announced that it has completed enrollment in its Phase 2 proof-of-concept (\"POC\") study evaluating the therapeutic potential of LPCN 1148 for the management of decompensated cirrhosis of various etiologies. Lipocine intends to explore partnering LPCN 1148.\n\n \n \n \n \n \n \n\n \n\"We are excited to complete enrollment which leads to topline results mid-2023 for a serious end-stage condition with high unmet medical need,\" said Dr. Mahesh Patel, President and CEO of Lipocine Inc. \"Muscle disorder and hepatic encephalopathy (HE) are highly prevalent in cirrhotic patients, adversely impacting survival rates. We believe LPCN 1148 has the potential to improve quality of life, prevent or reduce the occurrence of new decompensation events (e.g., HE, ascites, etc.), and improve post liver transplant survival, including outcomes and costs, for those with cirrhosis.\"\nThe ongoing Phase 2 POC study is a prospective, multi-center, randomized, placebo-controlled two-stage in male sarcopenic cirrhotic patients. Subjects have been randomized to one of two arms. The treatment arm is an oral dose of LPCN 1148, and the second arm is a matching placebo. The primary endpoint is change in skeletal muscle index at week 24. Key secondary endpoints include change in liver frailty index and myosteatosis, rates of breakthrough HE, and number of waitlist events including all-cause mortality. Total treatment duration (placebo controlled - stage 1, and the single-active arm, open-label extension - stage 2) is 52 weeks. For more information, refer to ClinicalTrials.gov NCT04874350.\nAbout Liver Cirrhosis\nDecompensated liver cirrhosis is estimated to affect more than 500,000 Americans, with men affected at twice the rate of women, and results in approximately 45,000 deaths every year. The only cure, liver transplant, has a high economic burden (~$878,500/transplant). The hypothalamus-pituitary-gonadal axis is profoundly altered in advanced cirrhotic patients, leading to endocrine dysfunction. Subjects with cirrhosis have impaired hepato...