[Edaily Reporter KIM SUNG-JIN ] KANGSTEM BIOTECH CO., LTD.(217730)has achieved statistical significance in the Phase 2a clinical trial of “OSCA,” a treatment for knee osteoarthritis currently under development. The company plans to rapidly proceed with follow-up clinical trials to accelerate the development of the new drug.

On the 29th, KANGSTEM BIOTECH CO., LTD. held a briefing session at the FKI Tower in Yeouido, Seoul, to present the results of the OSCA Phase 2a clinical trial and announced the trial’s success. The trial evaluated the safety and efficacy of the drug in 113 patients with moderate knee osteoarthritis, comparing a moderate-dose group with a high-dose group.

The drug was administered in medium- and high-dose groups, and the results were compared with those of a placebo group. At the 24-week mark, the treatment groups demonstrated superior results compared to the placebo group. The treatment groups outperformed the placebo group across all metrics—including VAS, IKDC, WOMAC, and KOOS—which measure pain levels and the degree of discomfort in daily life.

In particular, KANGSTEM BIOTECH CO., LTD. viewed the confirmation of structural improvement—in addition to pain relief—as encouraging. Bae Yo-han, Head of Clinical Development at KANGSTEM BIOTECH CO., LTD., who presented the findings, stated, “It is not easy to obtain direct evidence of structural improvement at the 24-week mark, but we confirmed significant results in the MOCART total score,” adding, “This is of tremendous significance, and its impact will be quite substantial.” Structural improvement refers to the recovery of damaged cartilage; in this case, cartilage recovery—which typically requires 1 to 2 years of follow-up to observe—occurred in just six months.

MOCART is an MRI-based assessment metric; in these results, the medium-dose group scored 2.32 points higher and the high-dose group 1.78 points higher compared to pre-trial (baseline) measurements. Although no strikingly large difference was observed compared to the change in the placebo group (-0.86 points), the company viewed the confirmation of a consistent trend positively.

Division Head Bae stated, “Although we did not achieve statistical significance in the high-dose group, a clear trend toward improvement in the same direction was evident,” adding, “Once data from the 12-month mark is available and the sample size increases, this trend will become even more pronounced.”

In the WORMS (Worms) score—an indicator that evaluates the degree of structural damage from osteoarthritis using MRI scans of the entire knee—there was no significant difference between the test group and the placebo group. The change score for the medium-dose group was 1.40, and for the high-dose group, it was 0.72, while the placebo group’s change score was 1.66. In the WORMS score, a higher score indicates a worse condition.

Based on these clinical results, KANGSTEM BIOTECH CO., LTD. plans to quickly move forward with follow-up clinical trials. Division Head Bae stated, “Based on the current results, we are preparing a strategy to complete the follow-up clinical trials as quickly as possible and proceed to commercialization.”

KANGSTEM BIOTECH CO., LTD. plans to present these clinical results at international conferences starting this November and aims to secure approval by May of next year following preparations for the follow-up clinical trial. Based on this, the company plans to begin the follow-up clinical trial in August of next year and submit a clinical trial application to the U.S. Food and Drug Administration (FDA) in December.

KANGSTEM BIOTECH CO., LTD. dismissed as false the rumors circulating in some quarters regarding plans to issue convertible bonds (CBs). Lee Gye-jong, Chief Financial Officer (CFO) of KANGSTEM BIOTECH CO., LTD., explained, “The company is not currently in a situation where it can only operate if funds are raised,” adding, “While we did consider issuing convertible bonds under exceptionally favorable terms, we decided not to proceed with the issuance in accordance with our internal policy of not issuing them unless such conditions are met.”