MEDIPOST has formally started phase 3 clinical trials in the United States for Cartistem, an allogeneic umbilical cord blood-derived mesenchymal stem cell therapy.
The company said on the 8th that it completed the first patient enrollment for the U.S. phase 3 trial targeting patients with knee osteoarthritis and the first patient treatment (FPT) with Cartistem.
Cartistem is a stem cell therapy for knee osteoarthritis that is approved and sold in Korea.
This clinical trial will be conducted at about 70 sites in the United States and Canada with 300 patients with knee osteoarthritis. Patient enrollment and treatment will take about two years, followed by two years of follow-up to evaluate improvements in cartilage structure and clinical symptoms.
According to the company, the U.S. Food and Drug Administration (FDA) approved this trial as a single pivotal study. The company said, "Based on recognition of domestic and Japan clinical results and more than three years of long-term real-world evidence (RWE) from about 560 domestic patients, we were allowed to proceed with the approval process in the United States with a single phase 3 trial."
After completing the trial, the company plans to prepare a clinical study report (CSR) and submit a biologics license application (BLA) to the FDA.
MEDIPOST plans to expand into Europe and China after obtaining approvals in the United States and Japan. Alongside the U.S. trial, it will also pursue local business development (BD) to accelerate its entry into the global market. In Japan, it recently completed phase 3 and is proceeding with the approval process.
Lee Seung-jin, head of global business at MEDIPOST, said, "The first patient dosing in the U.S. phase 3 trial is an important milestone for our global expansion," adding, "In the United States, the world's largest pharmaceutical market, we will prove Cartistem's therapeutic value and change the treatment paradigm for knee osteoarthritis."
Meanwhile, MEDIPOST secured the final clinical study report (CSR) for the Japan phase 3 trial and released the results in May this year. It plans to apply for Japanese marketing approval at the end of this year and aims to obtain approval in 2027.
In December last year, the company signed an exclusive sales license agreement for Japan with the Japanese pharmaceutical company Teikoku Seiyaku, securing 11.8 billion won as an upfront payment and 14.8 billion won in regulatory milestones. After marketing authorization and product launch, it is also set to receive revenue from the supply of finished goods and additional milestones tied to sales performance.