LG Chem Receives Approval for NASH (Non-alcoholic steatohepatitis) Treatment for Clinical Phase 1 Trial by the USA FDA
■ Approval to conduct clinical trials for candidate material with mechanism for suppressing liver inflammations based on outstanding pre-clinical results
■ Scheduled to evaluate safety, pharmacokinetics, etc. for healthy adults
■ Goal to procure distinguished competitiveness by improving safety of existing candidate materials with the same mechanism
LG Chem will begin clinical development for new NASH (non-alcoholic steatohepatitis) disease drugs in the United States.
Regarding this, LG Chem announced that it received approval for phase 1 clinical trials from the US FDA based on the outstanding pre-clinical study results of the new NASH treatment drug candidate material ‘TT-01025’ on the 2nd of Dec.
With this approval for phase 1 clinical trials, LG Chem conducted research on evaluating the safety, pharmacokinetics (absorption, distribution, metabolism and discharge process of drugs) for healthy adults at the clinical study institute ‘PPD Las Vegas (PPD’s clinical research unit in Las Vegas).’
‘TT-01025’ is a pipeline implemented with the goal of global exclusive development and commercialization, excluding in China and Japan, from China’s biotech company ‘TransThera Biosciences’ in August, and it is a candidate material 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 reason for suspending clinical trials of candidate materials with the same mechanism in the past.
NASH treatment is an untapped market with no treatments due to the high difficulty for developing new drugs, and it is expected that the number of patients will continue to increase due to the growing number of people with obesity, which is a major cause for the disease.
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 because more than half of them are in the US, preoccupying the US market appears to be of utmost importance.
Global Innovation Center Director Manfred Stapff of LG Chem who will be in charge of local clinical trials in the US said, “If NASH disease, which does not have any apparent symptoms, is not treated at the right time, it can become a silent disease that can even lead to cirrhosis that can require liver transplants,” and added, “I am pleased to be able to take on this challenge for developing innovative new drugs in the NASH sector that is still quite unexplored.”
TransThera’s Vice President of Biology Jennifer Sheng said, “Despite the global pandemic, we were able to effectively prepare for clinical studies and receive approval promptly through smooth cooperation between our two companies,” and added, “We will take another step toward the successful development of a new global drug together with LG Chem that is equipped with global clinical and commercialization capacities.”
Meanwhile, LG Chem possesses over 20 candidate materials (pre-clinical stage or higher) in anti-cancer, immunological disorders, and metabolic diseases. Among them, clinical studies are currently being carried out for candidate materials to treat gout, immunological diseases, and obesity treatment in the United States, and with the addition of the NASH treatment candidate material, LG Chem now has a total of four clinical projects in the US. LG Chem plans to select promising projects among candidate materials in pre-clinical stages to continue to expand clinical studies in the US.