Kolon TissueGene (950160.KQ) will analyze the results of the second U.S. Phase 3 trial of its osteoarthritis cell and gene therapy "TG-C" through an external professional statistics firm, a contract research organization (CRO). The move aims to restore market confidence after the company failed to secure statistical significance in the first trial, which it analyzed internally, and amid allegations of an internal information leak.
In a shareholder letter issued under the names of co-CEOs Roh Moon-jong and Chun Seung-ho on the 27th, Kolon TissueGene said, "To further strengthen objectivity and transparency, the analysis of the second study results of the ongoing Phase 3 trial will be conducted independently and thoroughly through a CRO with globally recognized credibility."
Kolon TissueGene disclosed on the 20th of this month that it had failed to meet the primary endpoint in the first Phase 3 trial. The placebo group, which received a saline solution, showed an improvement 0.5 points greater than the TG-C group on the Visual Analog Scale (VAS). On the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), TG-C showed an improvement of 1.07 points more than the saline group, but did not secure statistical significance. It also failed to achieve all of the secondary endpoints, which assess joint recovery. That analysis was handled by Kolon TissueGene's internal statistics team.
The company also emphasized that it had established an independent investigation body to probe allegations of a stock price decline that occurred before the announcement of the trial results. "We have strictly prohibited stock trading by executives and employees, and have maintained the highest level of security in the relevant departments handling clinical data," Kolon TissueGene said. "Regarding the allegations raised, we will do our best to actively resolve them, including by establishing an independent investigation body." The company's stock closed at 62,100 won on the 16th, the last trading day before the results announcement, down 20.28% from the previous day.
The company added, "We sincerely apologize for causing deep disappointment and concern with the announcement of the first results of the TG-C U.S. Phase 3 trial." It stressed, "We will restore trust not through excuses or vague hopes, but through scientific data and responsible action." It further said, "The only path to restoring lost trust is not grand words but certain results," adding, "We will devote all our capabilities toward the goal of becoming the world's first osteoarthritis cell and gene therapy."
