· The company will begin to evaluate the safety and efficacy in 130 patients with mild to moderate knee osteoarthritis
· The phase 2 trials for CARTISTEM® targeting patients who would undergo high tibial osteotomy with the drug as concurrent therapy, which were interrupted due to the COVID pandemic, also resumed and are expected to accelerate the drug’s entry into the Japanese market
CARTISTEM®, MEDIPOST’s blockbuster treatment for knee osteoarthritis, entered phase 3 clinical trials in Japan.
MEDIPOST (CEO: Yang Yoon-sun, KOSDAQ 078160) announced on the 25th the beginning of the phase 3 clinical trials of CARTISTEM®, a treatment for knee osteoarthritis. The drug received approval from Japan’s Ministry of Health, Labor and Welfare in February last year. This makes CARTISTEM® Korea’s first regenerative drug to enter phase 3 immediately after being exceptionally approved to skip phase 1 and phase 2 clinical trials in Japan, in recognition of Korean clinical trial results.
Japan’s phase 3 clinical trial will involve 130 patients with mild to moderate knee osteoarthritis (K&L grade 2-3). The patients will be divided into two groups. After administering one group with CARTISTEM® and the other group, the control group, with hyaluronic acid injections, joint function improvement, pain relief, and regeneration of damaged knee cartilage will be analyzed and compared through a 52-week follow-up.
In addition, the phase 2 clinical trials of CARTISTEM® targeting patients who would undergo high tibial osteotomy (HTO) with the drug as concurrent therapy, which were temporarily suspended due to the COVID-19 pandemic, resumed in Japan. The resumed phase 2 clinical trials will evaluate the safety and efficacy of the drug in 50 patients with mild and severe (K&L grades 2-4) knee osteoarthritis by comparing the control group treated with HTO alone and the test group treated with both CARTISTEM® and HTO.
A MEDIPOST official said, “Our clinical trials in Japan were delayed much more than planned due to the pandemic, but the drug’s safety and efficacy were recognized in Japan. As demonstrated by the fact that the drug did not have to undergo phase 1 and 2 trials and entered phase 3 immediately, we expect that our clinical trials will proceed smoothly in Japan.” The official added, “We also expect that the successful completion of clinical trials in Japan will elevate the status of Korean biotechnology by becoming the first stem cell treatment for knee osteoarthritis in Japan.”
Meanwhile, with the clinical data obtained from Korean trials approved in the US, the drug will skip phase 2 trials and enter phase 3 trials in the US. MEDIPOST plans to speed up the drug’s entry into the US, the world’s second-largest knee osteoarthritis market after Japan.
High Tibial Osteotomy (HTO) : A treatment for deformed knee arthritis that reduces pain by correcting genu varum (bow legs). When knees afflicted by degenerative knee arthritis are left untreated, the weight load on the knees leads to genu varum. High tibial osteotomy is used to treat such cases.