JW Pharmaceutical, "Phase 3 application to the European Medicines Agency in the first half of the year"
![[Photo courtesy of LG Chem and JW Pharmaceutical]](/news/photo/202303/135930_123755_3129.jpg)
A representative example of an undertreated condition is ‘gout’.
Gout is a metabolic disease in which uric acid is not excreted through the urine but accumulates in the body. The urate crystals are deposited in the soft tissues around the joints, causing acute inflammation and pain.
90% of patients are "hypo-excreters," meaning they have trouble excreting uric acid, and the rest are "hyper-producers," meaning they produce too much uric acid.
According to the pharmaceutical industry on March 7, LG Chem and JW Pharmaceutical are speeding up the development of new gout drugs. The two companies’ clinical trials are expected to end in December 2025. Although the plans for phase III clinical trials of the gout drugs have been suspended in some countries, the two companies are proceeding with research and development as scheduled.
First, LG Chem's tigulixostat (LC350189) is a gout drug for patients with excessive uric acid production. It inhibits the expression of xanthine oxidase, a uric acid-producing enzyme and is being developed to replace allopurinol, a first-line treatment of gout.
In February, LG Chem obtained approval for a phase 3 clinical trial (IND) of tigulixostat from the Korean Ministry of Food and Drug Safety. The Phase 3 trial will evaluate the efficacy and safety of tigulixostat in approximately 2,600 patients with gout compared with the existing treatment, allopurinol.
In the previous phase 2 study, 78% of the treatment group with 200 mg dose, the highest dose, achieved a serum uric acid concentration of less than 6 mg/dL. In the existing drug febuxostat group, 54% showed the same efficacy.
An official from LG Chem said, "There is a huge unmet demand for gout treatment globally, and we plan to reapply for a European IND after further consultation and focus on development with the aim of global commercialization in 2027.“
Epaminurad (URC102), a gout drug being developed by JW Pharmaceutical, is a uric acid excretion promoter. It is a new drug candidate for gout caused by hyperuricemia, an abnormally high concentration of uric acid.
In November last year, JW Pharmaceutical obtained approval for a multi-country phase 3 clinical trial of epaminurad from the Korean Ministry of Food and Drug Safety. The purpose of the phase 3 trial is to evaluate the efficacy and safety of epaminurad in reducing blood uric acid compared with febuxostat, the control drug.
The clinical trial involves a total of 588 individuals who are suffering from gout in Korea, Taiwan, and Europe.
Meanwhile, the Korea Health Insurance Review and Assessment Service has reported that the number of gout patients in Korea has risen by approximately 28% from 395,154 in 2017 to 492,373 in 2021. This increasing trend in gout cases has been seen globally.
Market research firm Grand View Research estimates that the current global market for gout drugs valued at 3 trillion won, is expected to grow to 10.7 trillion won ($8.3 billion) by 2025.
[WIKI KOREA=Cho Eun, Reporter]
choeun@wikileaks-kr.org
