Korean LG Chem & Chinese Biotech Partner Bring New NASH Drug into Phase 1 Clinical Trials in America

Korean LG Chem & Chinese Biotech Partner Bring New NASH Drug into Phase 1 Clinical Trials in America

Korea-based LG Chem alongside its biotech partner TransThera Biosciences has submitted an application to initiate clinical trials investigating its NASH (non-alcoholic steatohepatitis) pipeline known as TT-01025 to the United States Food and Drug Administration (FDA). More specifically, LG Chem filed its investigational new drug application (IND) seeking FDA nod to proceed with human studies in the United States addressing this rapidly growing disease.

NASH Crisis

TrialSite has noted that NASH is a public health crisis in the making. A type of NAFLD (nonalcoholic fatty liver disease), this chronic ailment involves the buildup of fat in the liver regardless of alcohol consumption. This condition can transform into liver cancer, reports Korea Biomedical Review. See TrialSite’s The Emerging NASH Crisis.” 

Analyst firm GlobalData’s Epidemiology Analysis estimates over a combined 60 million NASH patients in seven countries with a huge medical market such as the U.S., Japan, Germany, France, England, Italy and Spain, and it was reported that more than half of them are in the  US.

TT-01025

This investigational product 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 of the liver.

Preclinical Study

LG Chem reports that this new NASH pipeline known as TT-01025 demonstrated a high amount of selective action for VAP-1 protein, suggesting positive prospects for the development of safe and effective treatments with less “drug interaction,” which indicates failures of past attempts.

Challenging R&D Market

LG Chem reported in a company press release, “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.” The company further declared, “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.”

The Sponsors

LG Chem is Korea’s largest chemical company based in Seoul. By 2017, it was the 10th largest chemical firm in the world as measured by revenues. Their Life Sciences division is led by Jeewoong SonTransthera Biosciences is a venture based in China. They focus on the discovery and development of small molecule-based new drugs. Founded in 2016, the venture has raised $10 million.

The company was founded by Frank Wu, who has been educated in the U.S. with considerable biotech experience, including five years at Boehringer Ingelheim, the world’s largest privately held pharmaceutical company based out of Germany.

Call to Action. TrialSite monitors NASH studies—any readers interested in tracking this or others sign up for the daily Newsletter.

Responses