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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Kangstem Biotech is recruiting clinical candidates for 'OSCA' 2a, a treatment for knee osteoarthritis...Faster than expected
04
2025.09
- The Phase 2a clinical trial of OSCA, Kangstem Biotech’s investigational therapy for knee osteoarthritis, is progressing smoothly.
The Phase 2a clinical trial of OSCA, Kangstem Biotech’s investigational therapy for knee osteoarthritis, is progressing smoothly. As of early September, the company announced that more than 80 participants had been enrolled, with 56 already completing dosing. The dosing of all 108 patients is expected to be finished by the end of October, ahead of the original year-end schedule.
Yo-han Bae, Head of Clinical Development at Kangstem Biotech, commented,
“Thanks to the active cooperation of the participating investigators, both enrollment and dosing are proceeding smoothly, with protocol compliance and data management being carried out stably.”
He continued,
“The improvements in pain relief and joint function confirmed in the Phase 1 trial are also being reproduced in Phase 2a. If the expected level of results is achieved, it will be of great help in preparing for a Pre-IND meeting with the U.S. FDA next year.”
The current Phase 2a trial will be officially completed at the end of April next year, once the six-month observation period ends. Following data analysis, the company expects to announce topline results between late June and early July.
After the completion of the Phase 2a trial, Kangstem Biotech plans to immediately initiate a domestic Phase 2b trial while simultaneously accelerating the process for entering the U.S. market. In April, the company was selected for the “Advanced Consulting for Global Expansion in the Pharmaceutical Industry” program by the Korea Health Industry Development Institute, and it is working with a global biotech consulting CRO to prepare for next year’s Pre-IND meeting. These preparatory efforts are also considered an important process to enhance the clinical appeal of OSCA for multinational pharmaceutical companies in future global licensing negotiations.
Meanwhile, the company emphasized findings from its internally developed simulation model. Using medium- and high-dose data from the earlier Phase 1 trial to estimate treatment group efficacy, and incorporating the highest placebo effects observed in previous DMOAD (disease-modifying osteoarthritis drug) trials, the interim Phase 2a data are showing outcomes that exceed the model’s predictions. By the end of this year, six-month observation data from more than 30 patients will be available, enabling more reliable analysis.
A Kangstem Biotech representative concluded,
“Faster-than-expected patient enrollment and the positive simulation outcomes are raising expectations that OSCA could become the world’s first true DMOAD. We anticipate these results will also positively impact both domestic and global clinical development, as well as ongoing licensing discussions.”