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- -Phase 3 IND approvals completed in 5 Asian countries, including Korea... Efficacy in reducing blood uric acid and safety to be rigorously evaluated
- -hURAT1 inhibition mechanism promotes uric acid excretion... Expected to be a 'Best-in-Class' global gout treatment
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January 2024
JW Pharmaceutical announced on the 15th that it has received approval from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) for the Phase 3 clinical trial (IND) of its gout treatment, Epaminurad (code name URC102).
The Phase 3 trial of Epaminurad will evaluate its efficacy (blood uric acid reduction) and safety compared to febuxostat in a total of 588 gout patients across five Asian countries, including Korea.
With this approval, JW Pharmaceutical has now received all necessary multinational Phase 3 IND approvals for Epaminurad. In Korea, the IND was approved in November 2022, and patient enrollment and dosing began in March last year. In Taiwan, the IND was approved in August 2023, with the first patient registered by December. Subsequently, IND approvals were obtained in Thailand and Singapore in September.
Epaminurad, developed as an oral medication, selectively inhibits hURAT1 (human uric acid transporter-1), promoting uric acid excretion and is an effective candidate for hyperuricemia and gout, conditions characterized by abnormally high uric acid levels in the blood.
In the domestic Phase 2b clinical trial, completed in March 2021, JW Pharmaceutical confirmed Epaminurad's excellent tolerability and safety, meeting all primary and secondary efficacy endpoints.
Alongside the Phase 3 clinical trials, JW Pharmaceutical is also pursuing global technology licensing (License-Out) for Epaminurad. In 2019, it out-licensed the development and sales rights for China, Hong Kong, and Macau to Simcere Pharmaceutical Group.
A JW Pharmaceutical representative stated, “With the Malaysia IND approval, we can now proceed with Phase 3 clinical trials of Epaminurad across five Asian countries. Given the confirmed tolerability and safety in the previous Phase 2b trial, we aim to proceed with Phase 3 trials without setbacks to develop a Best-in-Class treatment for the significant unmet medical need in the global gout market.”
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.