- ACTiVION-II, the first of two US Phase 3 clinical trials, did not meet co-primary endpoints of VAS pain score and WOMAC total score at Month 12
- Results from ACTiVION-I, the second Phase 3 trial of TG-C targeting OA of the knee, anticipated in October 2026
- Kolon TissueGene to further analyze complete ACTiVION-II data
ROCKVILLE, Md., July 20, 2026 (GLOBE NEWSWIRE) -- Kolon TissueGene, Inc. ("the Company") (KOSDAQ: 950160), a biotechnology company developing novel advanced cell therapies for orthopedic diseases and other unmet medical needs, today announced topline results from the first of two US Phase 3 clinical trials of TG-C, a potential first-in-class cell and gene therapy targeting osteoarthritis of the knee (OAK). The Phase 3 ACTiVION-II study (NCT03291470) evaluated the efficacy and safety of a single intraarticular injection of TG-C versus placebo in patients with Kellgren-Lawrence (KL) Grade 2 or 3 OAK.
The Phase 3 ACTiVION-II study enrolled 531 randomized subjects across 27 U.S. clinical trial sites. TG-C did not demonstrate statistically significant improvements versus placebo in pain and function, and did not meet the co-primary endpoints of change from baseline in VAS (Visual Analogue Scale) pain and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) total score at Month 12. Additionally, the study did not meet any of the key secondary endpoints.
TG-C was generally safe and well-tolerated with no new or unexpected safety signals identified. The overall incidence, severity, and pattern of treatment-emergent adverse events were comparable between the TG-C and placebo groups, with the majority of events reported as Grade 1 or Grade 2 in severity. The observed safety findings were consistent with the known safety profile of TG-C and did not indicate any clinically meaningful safety concerns.
"While we are disappointed by the results from the first of two Phase 3 clinical trials of TG-C, we remain committed to advancing cell and gene therapy innovation targeting osteoarthritis of the knee," said Moon Jong Noh, PhD, Co-CEO of Kolon TissueGene.
Co-CEO of Kolon TissueGene, Seng Ho Jeon, added, "We are deeply grateful to the study participants, investigators and clinical trial sites for their contributions to the ACTiVION-II study over the last several years. We continue to analyze the full data set for additional insights and anticipate reporting results from the second Phase 3 clinical trial of TG-C in October 2026."
Topline results from ACTiVION-I, the second Phase 3 clinical trial of TG-C (NCT03203330) targeting OA in the knee, are anticipated in October 2026, after which Kolon TissueGene will determine next steps.
About Kolon TissueGene, Inc.
Kolon TissueGene, Inc., is a clinical stage biotechnology company developing first-in class cell and gene therapy candidates utilizing its cell-gene platform technology. The Company's lead product, TG-C, is an allogeneic cell and gene therapy candidate being evaluated in a Phase 3 clinical program, comprising two Phase 3 clinical trials, in the US under a Special Protocol Assessment (SPA) agreement reached with the US FDA. For additional information about Kolon TissueGene, Inc., please visit www.tissuegene.com.
About TG-C
TG-C is a first-in-class cell and gene therapy targeting OA of the knee through a single intraarticular injection. As an allogeneic (off-the-shelf) therapy, TG-C could provide an alternative to traditional treatment and surgery, or delay the progression of OA to minimize the need for multiple surgical interventions. Phase 2 clinical trials held in the US have demonstrated pain relief and increased mobility, as well indicators towards decreased progression of OA and improvements in joint structure. In a concluded US Phase 2 clinical trial, TG-C also demonstrated a two-year improvement of pain and function. TG-C is being evaluated in a Phase 3 program comprising two Phase 3 clinical trials.
SOURCE Kolon TissueGene, Inc.
Contacts:
Media and Investor Relations
ICR Healthcare
kolontissuegene@icrhealthcare.com
