JW Pharmaceutical said Wednesday that it has presented the results of phase 1 and 2a clinical trials for URC102, a gout treatment, at the 2017 American College of Rheumatology (ACR).
The drug, co-developed with Chugai Pharmaceuticals, a subsidiary of Roche, is a new drug candidate substance that is effective for “low-emission” gout, in which uric acid accumulates in the body without being released.
The phase 1 clinical trial for URC102 confirmed the safety and tolerability of the drug on healthy participants at the Seoul National University Hospital (SNUH).
The phase 2a clinical trial evaluated serum uric acid level decrease, efficacy, safety, and dose-dependent responses on 140 patients in 14 large hospitals, including SNUH.
In the trial, patients, who had a uric acid level of 7 to 10 milligrams per deciliter, were repeatedly administered with a total of eight levels ranging from 0.25 milligrams to 10 milligrams for 14 days. Results showed the uric acid level decreased as the dose increased.
Significant side effects associated with the URC102 administration was arthralgia, but there was no difference between the placebo and no severe side effects were present.
“Of all patients with gout, 90 percent of patients have low-emission gout,” said Han Seong-kwon 한성권, JW Pharmaceutical JW중외제약 CEO. “URC102 is a new drug that combines high drug safety and good efficacy.”
It is expected to contribute to disease improvement and quality of life for patients with gout, Han added. Gout is a disease the increase in uric acid in the body forms a crystal and deposits into the joint.
The number of patients with gout has increased over 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) next year.