South Korea-based LG Chem has reported top-line data from the Phase II CLUE clinical trial of LC350189, which showed substantial serum uric acid (sUA) reducing effects in chronic management of hyperuricemia in patients suffering from gout.
An inhibitor of xanthine oxidase, LC350189 is designed to reduce uric acid levels in the final product in purine metabolism.
In June 2019, the US Food and Drug Administration granted clearance to initiate the Phase II trial of LC350189.
The trial was conducted on 156 gout patients at 45 clinical centres in the US.
In the trial, subjects with chronic gout were given a once-daily oral dose of LC350189 50mg, 100mg or 200mg, or a placebo for three months.
The active control group enrolled 13 of the total 156 subjects to administer a febuxostat 40mg-80mg once daily dose.
The response rate reaching sUA less than 5mg/dL at the third month was the trial’s primary goal.
According to top-line results from the study, 47% of subjects in the 50mg LC350189 arm achieved the target sUA levels at the third month, along with 45% of participants in the 100mg arm.
Furthermore, 62% and 23% of subjects in the 200mg treatment arm and Febuxostat arm, respectively, had sUA less than 5mg/dL. Nearly 3% of subjects receiving placebo had similar levels.
On the secondary endpoint, 59%, 63% and 78% of subjects in 50, 100 and 200mg arms, respectively, were observed to have attained sUA less than 6mg/dL at the third month.
Nearly 54% and 3% of subjects in the Febuxostat arm and placebo arm, respectively, had similar levels.
LC350189 demonstrated a beneficial dose-dependent decrease in sUA levels, which reduced quickly in two weeks, and sUA levels lasted throughout the trial period.
The drug was noted to be well-tolerated in the trial subjects at all tested dose levels as against placebo.
LG Chem Life Sciences president Dr Jeewoong Son said: “Many gout patients could benefit from medicines with improved efficacy and safety profiles from the current standard of care.
“As LC350189 demonstrated in the CLUE study, we can be confident that LC350189 will be a better treatment option for gout patients in the near future.”