Company
Business
Stem Cell Therapy
Organoid
CDMO Business
IR Resource Center
Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
2025 Corporate Presentation
30
2025.04
On April 30, Kangstem Biotech held a corporate presentation, during which it shared updates from the 2025 OARSI and provided an overview of the clinical and business developments related to its osteoarthritis treatment candidate, OSCA.
On April 30, Kangstem Biotech held a corporate presentation, during which it shared updates from the 2025 OARSI and provided an overview of the clinical and business developments related to its osteoarthritis treatment candidate, OSCA.
Notably, the company revealed the final results of its Phase 1 clinical trial, including MRI findings disclosed for the first time.
The company confirmed OSCA's potential for disease-modifying effects in knee osteoarthritis based on clinical efficacy at both 6 and 12 months post-administration, as well as MRI comparisons at baseline and 6 months. Remarkably, despite being a Phase 1 trial, statistically significant improvements were observed at the 6-month mark across all efficacy indicators, including pain, joint function, and mobility(VAS·WOMAC p=0.002; IKDC·KOOS p=0.039). The therapeutic effect was also maintained or even enhanced at the 12-month follow-up. Pain reduction of 50–100% was reported in Phase 1 subjects, representing a level of improvement not seen with conventional treatments. At OARSI, held in Songdo, the company also unveiled MRI images for the first time, showcasing cartilage regeneration and subchondral bone improvement.
Professor Dae-Geun Seo, an orthopedic surgeon at Kyung Hee University Hospital and the presenter of the clinical results, stated: “In the medium-dose group, previously damaged cartilage identified at baseline was visibly restored at 6 months post-administration. In the high-dose group, where cartilage loss and subchondral bone edema were observed at baseline, post-treatment MRIs showed improvements in edema and smoother cartilage surfaces with signs of repair.” International attendees, including CEOs of cell therapy companies and university professors, expressed strong interest, commenting: “The pain reduction and joint
function improvements are very impressive,” and “We look forward to large-scale data showing structural improvement.”
Kangstem Biotech’s Head of Clinical Development added, “We’ve seenbetter-than-expected outcomes from both our Phase 1 study and ongoing 12-month long-term follow-up. We confirmed excellent safety and tolerability, and it is highly encouraging that all efficacy endpoints showed statistically significant and sustained
improvement from baseline, even at this early stage.” He also noted, “We’ve not only established structural improvement at the 6-month mark but also confirmed continued improvement at 12 months in the low- and medium-dose groups via MRI.” Based on these results, the company has expanded its Phase 2a trial to 108 participants(36 each in medium-dose, high-dose, and placebo groups), and recruitment and administration are currently progressing smoothly.