November 30, 2024

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LG Chem’s logo (LG Chem)

LG Chem has applied to carry out a phase 3 clinical trial of its gout treatment candidate Tigulixostat with the US Food and Drug Administration, the South Korean company said Monday.

If the application gets the go-ahead from the FDA, it will be LG Chem’s first phase 3 clinical trial of a new, self-developed drug candidate, according to the company.

Gout is a painful form of arthritis that is characterized by sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints, most often in the big toe. It is caused by an excessive level of uric acid in the blood.

Tigulixostat is an orally administered drug that can inhibit xanthine oxidase, which produces uric acid in the blood.

The testing will be carried out in the form of placebo controlled trials in 350 adult gout patients in the US and other countries over the course of six months, according to the company.

LG Chem’s previous phase 2 clinical trials under FDA supervision confirmed that Tigulixostat demonstrated strong effects in lowering the level of uric acid in the blood along with a safety level that was on par with the placebo controlled group.

LG Chem said the goal was to obtain FDA approval in 2027 and begin commercialization for the global market by 2028.

The company also plans to apply for a comparison trial with Alopurinol, an existing gout treatment, as it looks to prove Tigulixostat’s differentiated efficacy and safety for long-term use.

According to market tracker Coherent Market Insights, the gout treatment market is expected to reach $43 billion by 2027 from $26 billion in 2019. The number of gout patients across the world is estimated at 35 million with the US and China approximately accounting for 10 million and 14 million, respectively.

“Tigulixostat’s global phase 3 clinical trials will serve as a catalyst that improves LG Chem’s capabilities of testing new drugs, obtaining approvals, and producing and selling drugs,” said Son Jee-woong, president of Life Sciences Co. at LG Chem, in a statement.

“We will set up a new turning point for the gout treatment market through the preparations of clinical trial strategies that can secure global competitiveness as well as gearing up for preemptive commercialization.”

By Kan Hyeong-woo (hwkan@heraldcorp.com)