[Bio Focus] Doubts grow as LG Chem withdraws phase 3 clinical trial of gout drug once again

Phase 3 clinical trial in Europe retracted after cancellation in China

By Kwang-Ho Lee

LG Chem said in its regulatory filing on Tuesday that it dropped its plan to conduct a phase 3 clinical trial of its gout treatment candidate, Tigulixostat. Its decision to retract the trial in Europe was made after it cancelled its plan to carry out a phase 3 clinical trial in China last November.

The trial, also known by its trial name, EURELIA 1, is one of the two phase 3 clinical trials, which LG Chem had planned to compare a placebo with Tigulixostat by testing 350 patients from multiple countries. The other one, known as EURELIA 2, tests 2,600 patients to compare Tigulixostat with Allopurinol, a classical agent in treatment of gout. EURELIA 2 has progressed slightly later than EURELIA 1.

Doubts grow as problems occur in same trials in China, Europe
LG Chem received an approval from the U.S. for its plan for EURELIA 1. The study was therefore expected to go smoothly. However, the company is facing a setback in getting an approval from both China and Europe.

The situation is more serious in Europe than in China. When LG Chem retracted its clinical trial in China, the company explained that “we were not able to accept China’s request to conduct the clinical trial in accordance with the country’s standards, because our clinical trial was designed to meet the requirements in the U.S. and Europe.” This showed that the company focuses more on the Western countries than China.

However, it even pulled back its clinical trial in Europe, where it claimed to have satisfied the requirements. Doubts have therefore grown over LG Chem’s plan for clinical trials.

“Even if there remains questions about effectiveness, the U.S. tends to approve of phase 3 clinical trials, if there is no safety concerns,” a biopharmaceutical industry expert said in a general way, without giving a comment on LG Chem’s recent clinical trial. “Korea and Europe, on the other hands, tend to pay relatively more attention to effectiveness, when they give approvals for clinical trials.”

However, the result of the phase 2 clinical trial of Tigulixostat was not that bad, because 78 percent of patients administered with the largest dose of 200 milligrams were able to lower their uric acid levels below the target range. Considering that only 54 percent of patients administered with Febuxostat accomplished the goal, Tigulixostat can be considered more effective than the conventional gout drug.

300 milligrams added as ‘largest dose’ in phase 3 trial .
It is still unclear what the problem was, as the company refused to disclose detailed information. However, there was a difference between the phase 3 and phase 2 trials – the largest dose. During the phase 2 clinical trial in the U.S., the company used three types of doses – 50 milligrams, 100 milligrams and 200 milligrams. Among them, the 200 milligram-dose was most effective.

Based on the success, the phase 3 clinical trial was conducted with the doses of 100 milligrams, 200 milligrams and 300 milligrams. An LG Chem official explained that “we added the new type of dose, as we thought there would be no safety issue, even if we increase the amount.” Although LG Chem received an approval in the U.S. for its phase 3 trial that used the 300 milligram-dose, there could be a possibility that Europe questioned this.

“Unlike in China, we will reapply for the clinical trial in Europe after additional discussions,” the LG Chem official said. “Our company expects that things will get better.”

*This was translated from the article originally written in Korean. For more accurate information, please refer to the original version by using the link below. In case of discrepancies between the two versions, the Korean version shall prevail.

https://n.news.naver.com/article/374/0000318106

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