Kangstem Biotech(217730) said on the 29th that in phase 2a of the knee osteoarthritis treatment "OSCA," it confirmed not only pain and function improvement but also the potential for cartilage structure improvement.
The trial evaluated the safety and efficacy of the mid-dose and high-dose groups in 113 patients with moderate knee osteoarthritis and was conducted to explore the appropriate dose for subsequent studies. A total of 108 patients completed the 24-week follow-up, and no drug-related serious adverse events were reported.
Compared with before treatment, at 24 weeks patients who received OSCA saw greater improvements in pain and joint function than the placebo group. Cartilage assessment using magnetic resonance imaging (MRI) also achieved statistical significance, confirming the potential for structural recovery of damaged tissue.
Specifically, both the mid-dose and high-dose groups showed significant improvement over placebo in pain and function assessments. In structural assessments, the mid-dose group showed significant improvement over placebo, and statistical significance was confirmed in some detailed indicators such as the connectivity between cartilage and surrounding tissue and the surface of regenerated tissue. In the subchondral bone abnormality item, the high-dose group showed significant improvement over placebo.
In pain and function assessments, both the mid-dose and high-dose groups showed significant improvement over placebo. In structural assessments, the mid-dose group also showed significant improvement over placebo, and in detailed evaluations such as the connectivity between cartilage and surrounding tissue and the surface of regenerated tissue, some dose groups showed statistical significance. In the subchondral bone abnormality item, the high-dose group showed significant improvement over placebo.
Safety was also confirmed. No drug-related serious adverse events occurred in any dosing group. A total of three serious adverse events were reported, but all were cases of hospitalization or prolonged hospitalization, with no deaths, life-threatening events, or permanent disabilities.
Kangstem Biotech said the results showed a consistent trend with the six-month data confirmed in phase 1. A company official said, "We confirmed not only rapid pain relief and functional improvement but also the potential for recovery of damaged tissue," adding, "We expect the difference from placebo in structural assessments to widen in the 12-month follow-up results."
Kangstem Biotech plans to present these clinical results at the American College of Rheumatology (ACR Convergence 2026) to be held in Florida in Nov. The company plans to disclose the 12-month follow-up results at major conferences next year.
Na Jong-cheon, CEO of Kangstem Biotech, said, "It is significant that we reconfirmed in phase 2a the rapid effect and robust clinical results verified in phase 1," adding, "The consistency and reproducibility of the clinical results will be a key asset for designing subsequent trials and establishing development strategies, and we expect them to have a positive impact on joint development and technology transfer discussions with global pharmaceutical companies and biotechs."