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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Kangstem Biotech's OSCA Demonstrates Significant Clinical Efficacy and Structural Improvement in Moderate Knee Osteoarthritis
28
2026.07
- Phase 2a Trial Shows Statistically Significant Improvements Across All Endpoints Compared with Placebo and Confirms Subchondral Bone Structural Improvement
Kangstem Biotech announced today that it has received the topline results from its Phase 2a clinical trial of OSCA, the Company's investigational therapy for knee osteoarthritis.
At Week 24, analyses of changes from baseline demonstrated that, compared with placebo, the treatment groups achieved statistically significant improvements across all major clinical endpoints, including the 100-mm VAS, IKDC score, WOMAC, and KOOS Pain. MRI-based assessment using the MOCART score also demonstrated statistically significant improvement, supporting the potential for structural cartilage repair.
The Phase 2a study enrolled 113 patients with moderate knee osteoarthritis, with 38 patients assigned to the medium-dose group, 38 to the high-dose group, and 37 to the placebo group. A total of 108 patients completed the 24-week follow-up, while five patients discontinued the study. No significant differences in safety were observed between treatment groups, and no drug-related serious adverse events were reported.
Both the medium- and high-dose groups demonstrated statistically significant improvements versus placebo in patient-reported outcomes, including the 100-mm VAS, IKDC, WOMAC Total Score, and KOOS Pain. In structural assessments, the medium-dose group showed a statistically significant improvement in the MOCART Total Score compared with placebo (p=0.0263). Statistically significant differences were also observed in the MOCART subcategories of integration to border zone (medium dose, p=0.0377) and surface of the repair tissue (high dose, p=0.0424), as well as in the LFTJ subchondral bone parameter of the WORMS Delta sub-region assessment (high dose, p=0.041).
"The Phase 2a results are consistent with the six-month findings from our Phase 1 study, suggesting not only rapid pain relief and improved joint function, but also the potential for recovery of damaged joint tissue," said the Head of Clinical Development at Kangstem Biotech. "In particular, the MOCART findings indicate ongoing localized cartilage repair, while the WORMS results may represent early signals of disease modification through delayed disease progression and structural improvement. We expect the structural differences versus placebo to become even more pronounced at the 12-month evaluation."
Jong-cheon Na, CEO of Kangstem Biotech, said, "These Phase 2a results are particularly meaningful as they reaffirm the rapid onset of efficacy and robust clinical outcomes demonstrated in our Phase 1 study. The consistency and reproducibility of OSCA's clinical data will serve as a critical foundation for subsequent clinical development, and we expect these findings to further strengthen our ongoing discussions with global pharmaceutical companies regarding potential co-development and licensing opportunities."
