Kolon TissueGene's shares fell to the daily limit for the second consecutive day after the company announced it failed to achieve statistical significance in its Phase 3 clinical trial for the osteoarthritis gene therapy, TG-C, in the United States.
As of 9:10 a.m. on July 22, Kolon TissueGene's stock was trading at 30,050 won, down 12,850 won (29.95%) from the previous trading day. The stock has hit the price limit for two days in a row, marking a new 52-week low.
The decline in investor sentiment is attributed to the top-line results of the TG-C Phase 3 trial, which were disclosed on July 20.
In the trial conducted by the U.S. Food and Drug Administration (FDA) involving 531 patients with knee osteoarthritis, Kolon TissueGene reported that while the TG-C treatment group showed improvements in pain relief and joint function, it did not demonstrate statistical significance compared to the placebo group for both primary endpoints: pain (VAS) and joint function (WOMAC).
According to the announcement, the reduction in VAS pain scores at the 12-month mark was 38.7 points for the TG-C group and 39.2 points for the placebo group, with a difference of 0.5 points (p=0.8322). The total WOMAC score also showed a decrease of 27.61 points for the TG-C group and 26.54 points for the placebo group, resulting in a difference of -1.07 points (p=0.5701).
However, the company stated that no new safety concerns were identified. The 104-week follow-up indicated that TG-C was generally safe and well-tolerated, with no unexpected safety signals reported.
Kolon TissueGene is considering the possibility that a higher-than-expected placebo response may have influenced the results. The company plans to review the ongoing Phase 3 trial results in the U.S. alongside this data to discuss future FDA approval strategies.
* This article has been translated by AI.
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