GC WellBeing said Wednesday that preclinical research confirming the hepatoprotective effects of its placenta-derived injectable Laennec against alcoholic fatty liver disease has been published in the international journal Current Issues in Molecular Biology (CIMB).
The study was conducted jointly with a research team led by Professor Kang Ju-seop of Hanyang University College of Medicine. It focused on identifying the mechanisms by which Laennec suppresses fat accumulation in liver cells and alleviates oxidative stress in an alcohol-induced fatty liver animal model.
The findings showed that alanine aminotransferase (ALT) levels — a key marker of liver damage that rises sharply with alcohol consumption — fell significantly in a dose-dependent manner following Laennec administration. Liver tissue examinations also showed a marked reduction in fat accumulation and inflammatory cell infiltration.
Laennec also inhibited the activity of CYP2E1, an enzyme that generates reactive oxygen species and drives liver damage during alcohol metabolism, while activating STAT3 protein to promote hepatocyte regeneration and normalize the liver cells' antioxidant defense system.
GC WellBeing had previously demonstrated the efficacy and safety of high-dose intravenous (IV) drip administration of Laennec in a Phase 3 trial involving 226 patients with chronic liver disease in South Korea. Building on the new preclinical findings, the company plans to file for a product license change with the Ministry of Food and Drug Safety this year to add the intravenous administration route.
The publication is significant, the company said, because it scientifically establishes the mechanism of action behind one of its flagship long-selling products — which has surpassed cumulative shipments of 100 million ampoules — while strengthening the prescription evidence base ahead of the planned expansion to IV use.
"This research provides important academic support for the intravenous efficacy of Laennec," said Jeong Si-yeong, head of GC WellBeing's research and development division. "We will accelerate the approval process for expanding the IV administration route, drawing on both the preclinical mechanism findings and the Phase 3 trial results."
silverpaper@heraldcorp.com