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.
OSCA 2a phase IND change approval
25
2024.10
On the 24th, we received approval from the Korean Ministry of Food and Drug Safety to amend the IND for OSCA, an advanced biofusion drug for osteoarthritis, transitioning it to a Phase 2a clinical trial.
On the 24th, we received approval from the Korean Ministry of Food and Drug Safety to amend the IND for OSCA, an advanced biofusion drug for osteoarthritis, transitioning it to a Phase 2a clinical trial. The main reason for this amendment is to expand the patient cohort from fewer than 50 to 108 participants.
In Phase 1 of OSCA, a total of 12 clinical participants demonstrated safety and exhibited a 50-100% reduction in pain compared to pre-treatment levels. Notably, imaging assessments revealed promising results in cyst shrinkage, cartilage regeneration, and improvements in the structure of the subchondral bone, all of which are associated with symptom relief. We aim to validate these encouraging Phase 1 results by increasing the patient population in Phase 2a.
Additionally, we plan to enhance the value of the new drug by elucidating the mechanism behind OSCA's pain reduction, which will help clarify its distinction and lasting effects compared to existing treatments observed in Phase 1. By analyzing statistical validity and understanding the drug's mechanisms, we aim to increase the likelihood and appeal of a significant partnership with a global pharmaceutical company interested in developing the world's first DMOAD(disease-modifying osteoarthritis drug).
The Phase 2a trial will enroll 108 patients with moderate osteoarthritis, classified as ICRS (International Cartilage Repair Society) grades 3-4. The trial will evaluate the efficacy of two dosing groups (medium and high dose) at 6 months compared to a placebo, with efficacy also assessed at 12 months through a long-term follow-up study. The total duration of the Phase 2a trial will be 16 months, comprising 10 months for patient recruitment and dosing, followed by 6 months for efficacy observation in treated patients.
Meanwhile, OSCA is an advanced biofusion product that combines umbilical cord blood-derived mesenchymal stem cells with a cell-free cartilage matrix. It aims to be the world's first DMOAD. Notably, a single intra-articular injection into the knee joint cavity, without the need for surgery, is sufficient to achieve a fundamental therapeutic effect by enabling the administered cells to differentiate into chondrocytes and directly contribute to cartilage tissue regeneration.
https://n.news.naver.com/mnews/article/014/0005258363?sid=101