400,000 Annual Cases of 'Non-Alcoholic Fatty Liver Disease'... Pharmaceutical Industry Accelerates New Drug Development
Similar to Alcoholic Fatty Liver Even Without Drinking
Considered Causes of Cirrhosis and Liver Cancer
Many Major Pharmaceutical Companies Developing Treatments
[Asia Economy Reporter Lee Gwan-joo] The domestic pharmaceutical industry is accelerating the development of treatments for non-alcoholic steatohepatitis (NASH). NASH is identified as a major cause of liver cirrhosis and liver cancer, but since no commercialized treatment has yet been developed, it is considered a disease with very high demand for new drugs.
According to the pharmaceutical industry on the 10th, domestic pharmaceutical companies developing NASH treatments include Ildong Pharmaceutical, LG Chem, Yuhan Corporation, Hanmi Pharmaceutical, and Dong-A ST. The most recent achievement was by Ildong Pharmaceutical. On the 29th of last month, Ildong Pharmaceutical received FDA approval for clinical phase 1 trials of its new drug candidate ‘ID119031166M’. This candidate is being developed with an FXR (Farnesoid X receptor) agonist mechanism. FXR is known to be involved in liver lipid and glucose metabolism, bile acid synthesis and secretion, and inflammatory responses.
LG Chem’s NASH treatment candidate ‘LG203003’ also began dosing subjects in the US phase 1 clinical trial last month. LG203003 selectively inhibits the activity of DGAT-2, an enzyme involved in triglyceride synthesis, thereby suppressing fat accumulation in the liver. It is being developed as a once-daily oral medication, expected to provide high medication adherence convenience.
Hanmi Pharmaceutical’s representative innovative new drug, ‘LAPSTripleAgonist’, is smoothly progressing through global phase 2 clinical trials following a unanimous recommendation from the independent Data Monitoring Committee (iDMC) in May. Yuhan Corporation licensed its NASH drug ‘YH25724’ to global pharmaceutical company Boehringer Ingelheim and began European phase 1 clinical trials in November last year. Dong-A ST announced in June this year that it confirmed improved efficacy on key indicators in non-clinical results for ‘DA-1726’ in NASH treatment.
NASH refers to a condition showing similar features to alcoholic fatty liver disease despite little or no alcohol consumption. It is considered a causative disease for liver cirrhosis and liver cancer, with 20% of patients progressing to cirrhosis and subsequently to liver cancer. The disease spectrum is diverse, causing not only fat accumulation in the liver but also liver inflammation and fibrosis. The prevalence is not insignificant, reported to be 10-24% among the general population and 58-74% among obese individuals. According to the Health Insurance Review & Assessment Service, the number of NASH patients in Korea increased by 43.4%, from 283,038 in 2017 to 405,950 last year.
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However, there is still no officially approved treatment by the FDA or the European Medicines Agency (EMA). GlobalData, a UK-based data analysis and consulting firm, forecasts that the NASH treatment market will grow from 227 billion KRW last year to 36 trillion KRW by 2031. A pharmaceutical industry official said, "As NASH treatment development is actively progressing worldwide, continuous new drug development by domestic pharmaceutical companies is required to secure pharmaceutical sovereignty."
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