JW Pharmaceutical said Friday that it has received approval from the Ministry of Food and Drug Safety to go ahead with phase 2b clinical trials for URC102, a gout treatment.
The drug, co-developed with Chugai Pharmaceuticals, a subsidiary of Roche, is a new drug candidate substance effective for “low-emission” gout, in which uric acid accumulates in the body without being released.
The treatment had proved its efficacy, safety, and dose-dependent responses on 140 patients in 14 large hospitals, including Seoul National University Hospital, during its phase 2a clinical trials.
With the approval, the company plans to evaluate the effectiveness and safety of the drug on 167 patients with gout in 10 major domestic hospitals, including Chung-Ang University Hospital, Severance Hospital and Hanyang University Seoul Hospital.
“Although 90 percent of patients suffer from low-emission gout, existing drugs that promote uric acid discharge are not actively prescribed because of safety concerns,” a company official said. “As it is a disease with a high demand for an effective treatment, we plan to diversify our opportunities to advance into the global market with our phase 2b clinical trials.”
The number of patients with gout has increased more than 40 percent since 2012, according to the Health Insurance Review and Assessment Service. The global gout market is estimated to reach 3 trillion won ($2.6 billion) this year.
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