LG Chem Applies NASH Treatment for Clinical Phase 1 Trial in USA
■ Applied for clinical phase 1 trials in the US as a global promising project to suppress manifestation of liver inflammation proteins
■ Pre-clinical trial results expected to improve safety, which was a cause for suspending clinical studies on past drugs with the same mechanism
■ This means that pipeline competitiveness is being elevated through clinical studies in the US
LG Chem announced on the 23rd that it has submitted clinical phase 1 trial protocols (Investigational New Drug; IND) of the NASH (non-alcoholic steatohepatitis) treatment new drug pipeline TT-01025 to the US FDA together with its partner company ‘TransThera Biosciences’.
NASH is a chronic disease in which fat accumulates and inflammation, etc. occurs in the liver due to metabolism issues regardless of alcohol consumption, and when liver function damage continues, it can lead to cirrhosis or liver cancer.
TT-01025 is a NASH treatment pipeline implemented with the goal of global development and commercialization from China’s ‘TransThera Biosciences’ and is a treatment with a mechanism that suppresses manifestation of VAP-1 proteins known to be highly related with the progression of inflammation in the liver.
Pre-clinical study results showed that selective action on the target protein VAP-1 was very high and therefore, it is expected to be possible to develop a safe and effective treatment without ‘interaction between drugs’, which was a cause for suspending clinical trials of VAP-1 impeding drugs in the past.
LG Chem said, “As it is very difficult to develop new drugs in the NASH disease field due to the complex pathogenesis mechanism, it is a market that has very high future additional values if it can be developed successfully,” and added, “It is quite significant that clinical trials will be conducted in the United States, which is the largest market in the world, to enhance pipeline competitiveness.”
According to a global market survey (source: GlobalData's Epidemiology Analysis), there are over a combined 60 million NASH patients in seven countries with a huge medical market such as the US, Japan, Germany, France, England, Italy, and Spain, and it was reported that more than half of them are in the US.
Jeewoong Son (Executive Vice President / President, Life Sciences) stated, “We are expecting to enter the clinical trial stage faster than planned thanks to the systematic cooperation with TransThera Biosciences,” while adding, “We will speed up development for treatments that can significantly improve the lives of NASH patients worldwide.”