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| Researchers of LG Chem's life science division conduct new drug test in this photo provided by the company, Aug. 18. The company said Wednesday it received an U.S. Food and Drug Administration approval to initiate a phase 1 trial of treatment of nonalcoholic steatohepatitis. / Courtesy of LG Chem |
By Baek Byung-yeul
LG Chem said Wednesday that it has been given approval to commence a Phase 1 clinical trial of a liver disease treatment by the U.S. Food and Drug Administration (USFDA).
The company said the USFDA cleared its Investigational New Drug (IND) for the treatment of nonalcoholic steatohepatitis (NASH) for the trial.
LG Chem will begin the Phase 1 trial at the PPD Las Vegas Clinical Research Unit in Nevada, to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TT-01025, the candidate IND.
NASH is a chronic and progressive liver condition. It can be dormant for a long period of time, but once it accelerates, severe damage and cirrhosis can occur, which may result in liver failure or even cancer.
In August, LG Chem licensed the NASH treatment candidate TT-01025 from China's TransThera Biosciences. LG Chem also secured monopolistic development and sales rights of the treatment worldwide, excluding China and Japan.
LG Chem said the number of people struggling with NASH is expected to increase with the rise in obesity. There are no approved drugs to treat NASH so far.
According to GlobalData's epidemiology analysis, there are a total of 60 million people with NASH in seven major countries: the U.S., Japan, Germany, France, the U.K., Italy and Spain. LG said it is important for them to get a foothold in the U.S. market as more than half of people suffering from NASH live there.
"As a liver manifestation of a metabolic disorder, NASH is a potentially life threatening condition which increases cardiovascular risk and can lead to cirrhosis with the need for liver transplantation," Manfred Stapff, president of LG Chem Life Sciences Innovation Center, said.
"Since there is no specific treatment for NASH approved so far, we are proud to contribute to the clinical development of TT-01025 to address a significant medical need," he added.
Development of the NASH treatment is part of LG Chem's goal to make the biopharmaceutical businesses one of its main growth engines. The company has secured more than 20 candidate drugs including yet-to-be clinically trialed treatments for a range of cancers, immune disorders and metabolic diseases.
