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- -DSMB's primary evaluation based on safety data from gout patients is positive
- -Accelerating Phase 3 trials in five Asian countries, including Korea... Evaluating uric acid reduction efficacy and safety
- -hURAT1 inhibition mechanism promotes uric acid excretion... Expected to be a 'Best-in-Class' global gout treatment
February 2024
JW Pharmaceutical announced on the 14th that the U.S. Drug Safety Monitoring Board (DSMB) has positively assessed the primary results of the multinational Phase 3 trial of their gout treatment, Epaminurad (code name URC102), and recommended the continuation of the trial.
The DSMB, composed of experts in rheumatology, pharmacology, nephrology, and statistics, reviewed the Phase 3 clinical data of Epaminurad on January 31 (local time) to discuss the trial’s continuation.
The board unanimously recommended continuing the trial based on the review of safety data from currently enrolled gout patients.
Following this first DSMB decision, JW Pharmaceutical plans to accelerate the Phase 3 trial of Epaminurad, which is being developed as a Best-in-Class new drug.
Epaminurad, an oral medication, selectively inhibits hURAT1 (human uric acid transporter-1), promoting uric acid excretion. It is an effective candidate for treating hyperuricemia and gout, conditions characterized by abnormally high uric acid levels in the blood.
The Phase 3 trial of Epaminurad involves 588 gout patients across five Asian countries, including Korea, and evaluates its efficacy (uric acid reduction) and safety compared to febuxostat.
Alongside the Phase 3 clinical trials, JW Pharmaceutical is pursuing global technology licensing (License-Out) for Epaminurad. In 2019, they out-licensed the development and sales rights for China, Hong Kong, and Macau to Simcere Pharmaceutical Group.
A JW Pharmaceutical representative stated, “The recommendation from the first DSMB to continue the global clinical development of Epaminurad positively reflects the drug’s competitiveness, patient safety, and data reliability. We plan to accelerate the development of Epaminurad as a global gout treatment to address significant unmet medical needs.”
About Gout Treatments
Gout is classified into two types: the first is the 'underexcretion type,' where uric acid is not excreted effectively, unlike in healthy individuals, and the second is the 'overproduction type,' where the body produces more uric acid than normal. Currently, medications that decrease uric acid production are available, but treatments that promote uric acid excretion for underexcretion-type gout are not widely prescribed due to safety concerns for the kidneys and liver, despite the large number of patients. Additionally, allopurinol, a uric acid production inhibitor commonly prescribed as a first-line treatment, has weak effects at initial doses, and febuxostat is excluded as a first-line treatment in the US due to safety concerns. Therefore, the need for 'safe' gout treatments is greater than ever. In Phase 2 trials, Epaminurad met all primary and secondary efficacy endpoints and demonstrated excellent safety and tolerability in gout patients.
Gout Disease and Market Size
Known for causing extreme pain even with the slightest touch, gout is a representative intractable disease. With the westernization of dietary habits, the incidence rate among younger people has significantly increased, with the number of patients in Korea rising sharply from 334,705 in 2015 to 509,699 in 2022 (according to the Health Insurance Review and Assessment Service’s Healthcare Big Data Open System). Gout is a metabolic disease that occurs when uric acid produced in the body is not excreted through urine and accumulates. Uric acid remains in the blood or joint fluid in crystal form and deposits in cartilage, tissues around joints, or subcutaneous tissues, causing inflammation and pain. Common causes include regular meat consumption, excessive drinking, and overeating. Recently, it has been occurring across various age groups without age specificity. Like hypertension or diabetes, once it develops, it is considered a chronic intractable disease that requires continuous treatment. With the increasing number of patients, the gout treatment market is also growing significantly. According to a report by Grand View Research, the global gout treatment market, currently valued at approximately 3 trillion KRW, is projected to grow to about 10 trillion KRW (8.3 billion USD) by 2025.