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[[B1]] GC Cell Wellbeing said a preclinical study confirmed that its placenta-derived injectable Laennec protects against alcohol-induced fatty liver. Building on an earlier Phase 3 trial that demonstrated the efficacy of high-dose intravenous (IV) administration in patients with chronic liver disease, the company said it plans to accelerate efforts to expand the intravenous dosing method after securing additional evidence on the drug’s mechanism of action
[[B2]] GC Cell Wellbeing said on the 19th that the results of the preclinical study of Laennec, conducted jointly with a team led by Professor Kang Joo-sup of Hanyang University College of Medicine, were published in the <a href="https://healthylife7.com/third-international-dialogue-on-sustainable-financing-for-ncds-and-mental-health/” title=”Third International Dialogue on Sustainable Financing for NCDs and Mental Health”>international journal Current Issues in Molecular Biology (CIMB)
[[B3]] The research team administered Laennec intravenously twice a week to animal models in which fatty liver had been induced by alcohol. As a result, levels of alanine aminotransferase (ALT), an indicator of liver damage, decreased significantly in a dose-dependent manner, while fat accumulation and inflammation in liver tissue were also reduced
[[B4]] In an earlier Phase 3 trial involving 226 patients with chronic liver disease at 18 medical institutions in Korea, the high-dose intravenous drip group showed a statistically significant improvement in ALT change six weeks after administration, compared with the existing subcutaneous administration group. Based on these results, the company plans to apply to the Ministry of Food and Drug Safety within the year for a product change approval to add the intravenous dosing method. Jung Si-young, head of GC Cell Wellbeing’s research and development division, said the company will begin the approval process to expand the intravenous dosing method based on the mechanism confirmed in the preclinical study and the results of the Phase 3 trial.
#GCCellWellbeing#Laennec#FattyLiver#LiverDisease#Biopharma
Original reporting by Lee Yeon-soo for Seoul Economic Daily
AI-translated from Korean. Quotes from foreignxact original wording
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