MEDIPOST CEO Oh Won-il speaks at a press conference on Wednesday after the company said Cartistem met all primary and secondary endpoints in a Japanese phase 3 trial. (Credit: MEDIPOST)
MEDIPOST said Wednesday its stem cell knee osteoarthritis therapy Cartistem met all primary and secondary goals in a Japanese phase 3 trial, setting up a planned approval filing by the end of this year.
A Japanese approval would give the Korean biotech its first major overseas market for Cartistem, which is already sold in Korea. The company is targeting approval in 2027.
The 130-patient trial was run across 13 hospitals in Japan and compared Cartistem with hyaluronic acid, a standard injection used for knee pain. Patients were followed for 52 weeks.
Cartistem met both co-primary endpoints, MEDIPOST said. It showed a statistically significant benefit over hyaluronic acid on WOMAC, a measure of knee pain and function, and on ICRS grade, which assesses cartilage damage.
The WOMAC result reached a p-value of less than 0.0001, while the cartilage endpoint reached 0.0002, the company said. MEDIPOST did not disclose the absolute size of the treatment benefit in the release.
The drug also met all secondary endpoints, including VAS, IKDC and KOOS scores, which track pain and knee function. Serious adverse events seen in the study were not considered related to Cartistem, the company said.
Lee Seung-jin, head of MEDIPOST’s global business division, said the Japanese data mattered because the effect held across both clinical symptoms and cartilage measures.
He said the result also confirmed the cartilage-regeneration effect previously shown in Korea, giving MEDIPOST a basis to argue Cartistem could be a disease-modifying osteoarthritis drug, or DMOAD -- a higher bar than pain relief because it implies changing the course of the disease.
The Japanese data may also shape how MEDIPOST presents its U.S. program. The company said Cartistem showed statistically significant results on WOMAC and 100mm VAS, the same primary measures being used in its U.S. phase 3 trial.
Commercially, MEDIPOST already has a route into Japan. The company signed an exclusive sales agreement with Teikoku Seiyaku in December and said approval could bring revenue from finished-product supply and milestone payments.
The trial result also puts more weight on production.
Cartistem is not a pill that can be scaled by chemical synthesis. It is made from living cells, which means cell density, culture timing and batch consistency become part of the regulatory and commercial story.
MEDIPOST told Korea Biomedical Review that its process development team purchased Curiosis’ Celloger Stack-H live-cell imaging system after testing the device through a demo. The company said the equipment met its needs and that further work with Curiosis will focus on optimizing the system for GMP manufacturing sites.
MEDIPOST said the device is planned for Cartistem and future pipeline production. It is also checking whether the system can be used in preparations for Cartistem’s commercialization in Japan and the United States.
The company currently checks cell conditions in large multi-layer culture vessels using optical microscopes. With the Curiosis system, MEDIPOST said it expects to standardize cell-density assessment and decisions on when to subculture cells, while turning process-control indicators into more measurable data.
Kim Ji-hye
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