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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Initiation of Patient Dosing in OSCA Phase 2a Clinical Trial
26
2025.03
The clinical Phase 2a trial for "OSCA," a Disease-Modifying Osteoarthritis Drug(DMOAD) for osteoarthritis, has begun patient dosing.
The clinical Phase 2a trial for "OSCA," a Disease-Modifying Osteoarthritis Drug(DMOAD) for osteoarthritis, has begun patient dosing. The Phase 2a trial, which involves 108 participants, is expected to progress rapidly, as many patients who have developed expectations based on the Phase 1 results are already waiting for
treatment.
We have expanded the Phase 2a trial size from around 50 patients to more than 108, more than doubling the number. In particular, the positive results observed in Phase 1, including a 50-100% reduction in pain compared to pre-treatment levels, cyst reduction linked to symptom improvement, and regeneration of cartilage and subchondral bone, have formed the basis of our confidence. Through this Phase 2a trial, we aim to accelerate the new drug development by confirming the statistical significance of OSCA compared to the placebo group.
As the world enters an aging era, the global number of osteoarthritis patients is estimated to reach 600 million, and the market for related treatments is rapidly expanding. Existing treatments mainly focus on pain relief, and there is a high global demand for DMOAD capable of regenerating cartilage.
Meanwhile, Kangstem Biotech's OSCA entered into a domestic technology transfer agreement with YooYoung Pharmaceutical last year while conducting its Phase 1 trial. YooYoungPharmaceutical stated that the unique competitive advantage of OSCA lies in its ability to provide a fundamental treatment for osteoarthritis with just a single injection, without the need for surgery. Under this agreement, YooYoung Pharmaceutical will conduct the domestic Phase 2b and 3 trials, as well as the domestic sales and distribution of OSCA. Kangstem Biotech will be responsible for manufacturing and supplying the drug for clinical trials and domestic sales, receiving milestone payments and royalties based on sales once the product is marketed.
The OSCA Phase 2a trial, which completed its first patient dosing at Bundang CHA Hospital on March 25, targets 108 patients with moderate osteoarthritis classified as ICRS grade 3-4(International Cartilage Repair Society standard). The efficacy of a single dose of OSCA will be evaluated at the 6-month mark compared to the placebo group. The experimental group will be divided into medium and high-dose groups. Additionally, a 12-month efficacy evaluation will be conducted as part of a long-term follow-up investigation to confirm the long-term effects, which are a key requirement for a DMOAD.
The Phase 2a trial is being conducted at seven clinical trial institutions: Kyung Hee University Hospital, Kangdong Kyung Hee University Hospital, Yonsei University College of Medicine Gangnam Severance Hospital, Korea University College of Medicine Hospital, National Medical Center, Catholic University Uijeongbu St.
Mary's Hospital, and CHA Medical University Bundang CHA Hospital.