Over 80 patients enrolled by early September, with the total recruitment target set at 108 participants
[by Ji, Yong Jun] Kangstem Biotech announced on September 4 that, as of early September, more than 80 participants had been enrolled for the Phase 2a clinical trial of ‘OSCA,’ an investigational treatment for knee osteoarthritis, with 56 having completed treatment. The company projects that the full cohort of 108 subjects will be administered by the end of October, ahead of the initial year-end timeline.
"With active cooperation of researchers at participating sites, recruitment and administration are progressing smoothly. Protocol compliance and data management are also stable," expressed Bae Yohan, Executive Managing Director of the Clinical Development Division at Kangstem Biotech. "The analgesic and improvements in joint function observed in Phase 1 are being reproduced in Phase 2a. Should the anticipated outcomes be confirmed, this will represent a major step forward in preparing for 2026’s Pre-IND meeting with the U.S. Food and Drug Administration (FDA)."
The Phase 바카라 꽁 머니 clinical trial is scheduled to officially conclude upon completion of the six-month observation period in late April 2026. Subsequent data analysis is expected to enable the release of top-line results by late June or early July next year.
Kangstem Biotech plans to initiate follow-up clinical trials in Korea while simultaneously expediting entry into U.S. clinical trials. To this end, the company applied for and was selected in April for the Korea Health Industry Development Institute's (KHIDI) ‘In-depth Consulting for Pharmaceutical Industry Global Expansion’ program. In addition, Kangstem Biotech is collaborating with a global biotech consulting contract research organization (CRO) to prepare for a pre-IND meeting scheduled for next year.
"The rapid pace of patient recruitment, together with favorable simulation outcomes, has raised expectations that OSCA could emerge as the world's first oral disease-modifying osteoarthritis drug (DMOAD). Such progress will have a positive impact on Korean and international clinical trials, as well as on discussions regarding technology out-licensing," a Kangstem Biotech official said.