5 August 2022 - - South Korea-based pharmaceutical company LG Chem has submitted an IND application to the US FDA for its first independent global Phase 3 clinical trial of its new gout drug 'Tigulixostat' (clinical program name: EURELIA_1 Study), the company said.

LG Chem's strategy is to expand its life sciences business and to reach global markets such as the US and Europe in various therapeutic areas in the upcoming years.

In the global Phase 3 clinical trial, Tigulixostat will be evaluated in 350 adult gout patients with hyperuricemia for safety and efficacy at Month 6 of treatment, and the data will be compared with that of the placebo-controlled group.

The primary end point is the patient ratio reaching below 6mg/dL of serum uric acid concentration after six months of treatment.

Additionally, LG Chem will be submitting an application to the US FDA for a comparative study with 'Allopurinol,' a first line treatment of gout.

The company's strategy is to prove distinguished efficacy and safety for long-term treatment through global clinical trial.

LG Chem aims to enter the global gout market in 2028 after obtaining US FDA approval for Tigulixostat as a first line treatment.

Tigulixostat is an oral drug administered once daily. It inhibits enzymatic activity of 'XO (Xanthine Oxidase),' thereby reducing production of uric acid, which is the primary cause of gout.

Results from the US Phase 2 clinical trial--primary end point set at a challenging level (achieving below 5mg/dL serum uric acid concentration)--confirmed the potential of Tigulixostat as a new gout treatment distinguished from pre-existing drugs, while also demonstrating safety similar to that of the placebo group.

According to Coherent Market Insights, the global gout market value is projected to escalate from 2.6bn in 2019 to 4.3bn by 2027 due to the increase of aging and obese population.

Currently, 35m people are diagnosed with gout worldwide and it is estimated that there are 10 m and 14m gout patients in the US and China, respectively.

LG Chem Life Sciences is a business division within LG Chem, engaged in development, manufacturing and global commercialization of pharmaceutical products.

LG Chem Life Sciences seeks to expand and make global presence by focusing on key core therapeutic areas of Immunology, Oncology, and Metabolic Diseases (specifically, diabetes and related metabolic diseases).