Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session

Core Insights - Lipocine Inc. announced the publication of a Phase 2 trial manuscript for LPCN 1148, which shows promise in treating sarcopenia and hepatic encephalopathy in male patients with cirrhosis [1][2][5] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing therapeutics through effective oral delivery, with a proprietary technology platform [1][12] - The company has multiple drug candidates in development, including LPCN 1148, which targets liver cirrhosis and its complications [12][13] Clinical Trial Details - The Phase 2 trial (LPCN 1148-21-001) was conducted in two stages: a double-blind, placebo-controlled stage followed by a single-arm open-label extension [2] - The trial specifically evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation [2] Key Findings - At 24 weeks, LPCN 1148 therapy significantly improved sarcopenia compared to placebo, and participants experienced fewer episodes of overt hepatic encephalopathy [3] - Additional benefits included improvements in muscle quality, hemoglobin levels, and patient-reported symptoms [3] Industry Context - Cirrhosis is a severe liver disease with limited treatment options, affecting over 382,000 patients in the US, many of whom are awaiting liver transplants [6][7] - Overt hepatic encephalopathy is a common and debilitating complication of liver disease, with a high recurrence rate and significant impact on patient quality of life [8][9][10]