Medipost is ramping up the U.S. Phase 3 clinical trial of its knee osteoarthritis treatment, Cartistem.
Medipost said Wednesday that it has completed the first patient enrollment, treatment, and dosing in the U.S. Phase 3 trial of Cartistem, an allogeneic mesenchymal stem cell therapy derived from umbilical cord blood.
The U.S. Phase 3 trial of Cartistem will be conducted in more than 70 clinical trial sites across the United States and Canada, targeting 300 knee osteoarthritis patients. Patient recruitment and dosing will take about two years, followed by a two-year follow-up period to comprehensively evaluate structural improvement and clinical symptom improvement. After the trial is completed, the company plans to prepare a Clinical Study Report (CSR) and file a Biologics License Application (BLA) in sequence.
This trial received "single trial" approval from the U.S. Food and Drug Administration (FDA). Medipost had this clinical design recognized by presenting real-world evidence (RWE) based on treatment data from approximately 560 patients in Korea who had passed more than three years since dosing. Unlike the general requirement of two or more independent clinical trials, this trial reduced the number of recruited patients to half the level, allowing the company to cut clinical costs and accelerate development.
Cartistem is a knee osteoarthritis stem cell treatment already commercialized in Korea. Medipost recently completed the Phase 3 trial of Cartistem in Japan and is preparing follow-up approval procedures. Through this entry into the U.S. market, the company's strategy is to develop Cartistem into a disease-modifying osteoarthritis drug (DMOAD) based on cartilage regeneration.
"The first patient enrollment and the start of dosing in the U.S. Phase 3 trial is an important milestone for entering the global market," said Lee Seung-jin, head of Medipost's Global Business Division. "We will prove the therapeutic value of Cartistem in the United States, the world's largest pharmaceutical market, and change the paradigm of knee osteoarthritis treatment."
