LG Chem is accelerating efforts to develop a new gout treatment.
The company recently submitted applications for phase 3 investigational new drug (IND) clinical trials to the Chinese regulator, following the U.S., drawing attention to its future development process.
In a public notice on Monday, LG Chem said it has applied for 3 IND clinical trials of Tigulixostat, a new gout treatment candidate, to China’s National Medical Products Administration (NMPA).
The phase 3 clinical trial is a placebo-controlled clinical trial as part of the company’s global clinical trial, “EURELIA 1 Study” proceeding with placebo control. LG Chem made a similar IND application to the U.S. Food and Drug Administration on July 30.
The company plans to evaluate Tigulixostat’s efficacy in lowering uric acid in the blood and safety through the treatment period of six months. It expects some 350 subjects would participate.
LG Chem also plans to submit phase 3 IND trial applications to European countries to secure a sufficient number of participants.
There are more Tigulixostat-related clinical trials planned by LG Chem. On Sept. 1, the company submitted another phase 3 Tigulixostat clinical trial, EURELIA 2 Study, to the U.S. FDA.
Unlike EURELIA 1 Study, EURELIA 2 Study will proceed in comparison to the existing treatment of allopurinol.
LG Chem plans to assess its long-term safety of 12 months and efficacy on 2,600 adult gout patients with hyperuricemia in the U.S. and Europe. The primary endpoint is the share of patients with serum uric acid concentration of 6 mg/dL at the fourth, fifth and sixth months of administering the drug.
Accordingly, the number of subjects participating in Tigulixostat’s later clinical trials upon the entry of each phase will likely reach 3,000. The company aims to strengthen its global competitiveness by securing the status of primary treatment based on the upcoming trial results.
The gout treatment market is expected to expand sharply due to population aging and the increase in the obese population. According to the global market surveyor, Coherent Market Insights, the global gout therapy market is expected to grow from $2.6 billion in 2019 to $4.3 billion in 2027.
Tigulixostart is a drug that inhibits the expression of the uric acid-producing enzyme, Xanthine Oxidase (XO).
“We can expect patient compliance and convenience with quick medicinal efficacy from the oral gout treatments taken once a day," a company official said.