LG Chem files IND for Phase 3 study of gout drug in U.S.

[Source: LG Chem Ltd.]

South Korea¡¯s LG Chem has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its gout drug tigulixostat in a planned Phase 3 clinical trial, the company said on Monday.

LG Chem shares were uplifted by 2.49 percent to trade at 618,000 won ($475) in early Monday session.

The clinical trial is designed to evaluate the efficacy and safety of tigulixostat compared to placebo in 350 adult patients with hyperuricemia in multinational regions including the United States.

LG Chem is also planning for an additional IND application with the FDA for a clinical trial to compare tigulixostat and allopurinol, which is commonly used to treat gout and kidney stones. This large-scale study is designed to demonstrate efficacy and long-term safety of the drug in a broader range of patients around the world.

LG Chem aims to obtain marketing approval for tigulixostat as a first-line treatment from the FDA in 2027 and start a global launch from 2028.

The once daily tigulixostat inhibits the expression of xanthine oxidase (XO), an enzyme which produces uric acid, a major cause of gout. The investigational drug showed significant efficacy in the reduction of uric acid in Phase 2 clinical trials, according to the company.

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