Medipost (078160) said Tuesday that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct its Phase 3 clinical trial of Cartistem, a knee osteoarthritis treatment, as a single pivotal study. The company received approval for its Phase 3 clinical trial plan in the first quarter of this year and is currently conducting the trial, including patient recruitment.
According to Medipost, it is customary for Phase 3 trials seeking new drug approval from the U.S. FDA to involve at least two independent studies, including a pivotal trial and a confirmatory trial. However, the company explained that it received approval to proceed with a single trial based on previously secured clinical data from Korea and Japan, as well as treatment data from patients dosed in Korea.
The single-trial approval will allow Medipost to accelerate drug development while cutting costs. The total number of patients to be recruited has been reduced by 50%, from 600 to 300. The reduction in trial scale is expected to lower total clinical costs by approximately 20-30% compared with the previous plan.
The clinical trial period, previously estimated at about 48 months on a sequential basis, is also expected to be shortened to 42-45 months. "By maintaining the total number of clinical sites at 70 and concentrating patient recruitment, the pace of recruitment will further accelerate," a Medipost official said.
Lee Seung-jin, head of Medipost's Global Business Division, said, "This FDA decision is the result of having the reliability of our clinical data and the excellence of our protocol officially recognized by the world's top regulatory agency." He added, "We will mobilize all of our advantages in time and cost, along with our successful Phase 3 experience in Korea and Japan, to carry out the U.S. Phase 3 trial without setbacks."
Meanwhile, Medipost is also pursuing entry into the Japanese market. The company recently disclosed the results of its Phase 3 trial in Japan and aims to file for marketing approval in the second half of this year, with a goal of obtaining final approval within 2027.
