Lipocine Unveils 52-Week LPCN 1148 Phase 2 Results at EASL Congress 2024
Salt Lake City, June 10, 2024 – Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical firm, has revealed positive outcomes from its Phase 2 trial of LPCN 1148, a treatment aimed at cirrhosis. The results were showcased in a late-breaking presentation at the European Association for the Study of Liver (EASL) Congress on June 8 in Milan, Italy. Dr. Arun J. Sanyal from Virginia Commonwealth University delivered the presentation titled "Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy (HE) in patients with cirrhosis: a 52-week phase 2 randomized clinical trial."
Understanding Cirrhosis
Cirrhosis represents the final stage of liver diseases emerging from various causes such as alcoholic liver disease, chronic viral hepatitis, nonalcoholic fatty liver disease, and primary cholangitis. Patients with cirrhosis often endure severe complications like hepatic encephalopathy, variceal bleeding, and ascites, which necessitate frequent hospitalizations. Many patients also suffer from sarcopenia, characterized by low muscle mass. In the United States, over 382,000 individuals are diagnosed with decompensated liver cirrhosis. Liver transplantation remains the only curative option, but the scarcity of donor livers forces many patients to rely on limited supportive treatments while awaiting a transplant.
About Hepatic Encephalopathy (HE)
HE is a common and debilitating complication of liver cirrhosis, severely impacting patients and their caregivers. Patients with HE often experience neurological, psychiatric, and musculoskeletal impairments. The recurrence of HE episodes is high, with approximately 50% of cirrhosis patients expected to experience it during their lifetime. The underlying causes of HE include disrupted ammonia clearance and increased inflammatory cytokines. Despite standard treatments, HE recurrence is frequent, highlighting an unmet need for effective therapies. The one-year survival rate for patients with HE is about 50%, and cognitive impairments associated with cirrhosis lead to higher healthcare resource utilization.
Phase 2 Study Overview
The Phase 2 study was conducted across eight centers in the United States, involving 29 participants. The primary goal was to assess the efficacy of LPCN 1148 over 24 weeks in men with cirrhosis and sarcopenia, while the study’s secondary goal focused on the drug’s safety and tolerability. Post 24 weeks, all participants entered an open-label phase where they received LPCN 1148 continuously.
The study participants had an average Model for End-Stage Liver Disease (MELD) score of 16.8, with 97% having experienced at least one decompensation event prior to enrollment. Sarcopenia was measured using computed tomography (CT) scans, focusing on the skeletal muscle area at the third lumbar vertebra normalized by height (L3-SMI). Patients had regular visits every four weeks, with CT scans conducted at specified intervals to monitor progress. The trial imposed no restrictions on other standard treatments the patients were receiving.
About LPCN 1148
Lipocine is investigating LPCN 1148, which contains testosterone laurate, for the treatment of decompensated cirrhosis. LPCN 1148 aims to enhance the quality of life for patients on the liver transplant waiting list, reduce the occurrence of new decompensation events like HE, and improve post-liver transplant outcomes and survival rates.
About Lipocine
Lipocine Inc. specializes in developing therapeutics using its proprietary oral delivery technology. The company focuses on creating differentiated products for central nervous system (CNS) disorders and other conditions with significant unmet needs. Lipocine's development pipeline includes LPCN 1154 for postpartum depression, LPCN 2101 for epilepsy, LPCN 2203 for essential tremor, and LPCN 2401 for obesity management, among others. The company also seeks partnerships to advance its non-core assets. One of its notable FDA-approved products is TLANDO, an oral testosterone prodrug for male hypogonadism.
Lipocine’s future endeavors are marked by ongoing and forthcoming clinical trials, as well as plans for new drug applications and potential market introductions.
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