· SMUP-IA-01 phase 1 clinical data in Korea has been approved by the U.S. FDA, allowing the start of phase 2 clinical trial
· Clinical trials for treatment of knee osteoarthritis are in full swing in the U.S. and Japan, aiming to become the first successful global stem cell therapy
MEDIPOST now has the green light for its treatment lineup for knee osteoarthritis.
MEDIPOST (CEO: Yoonsun Yang, KOSDAQ 078160) announced on the 1st that clinical phase 1 data in Korea for SMUP-IA-01, an injectable drug for knee osteoarthritis, has been approved by the U.S. FDA, allowing to directly begin phase 2 clinical trial.
As a result of the pre-IND meeting with the U.S. FDA, phase 2 can begin with allogeneic stem cell therapy, which significantly reduces costs and time. This is the second feat following CARTISTEM®’s progress directly to phase 3 clinical trial in the United States.
In addition, phase 2 clinical trials of CARTISTEM® as a concurrent therapy with patients undergoing high tibial osteotomy (HTO), which were temporarily suspended due to the COVID-19 pandemic, have resumed in Japan and phase 3 trials have begun for CARTISTEM® alone, accelerating drug’s entry into the Japanese market.
“A strategy for entering the global market based on the outstanding clinical results proved in Korea will eventually increase the value of the pipeline and the possibility of commercial success,” an official of MEDIPOST said, emphasizing the importance of securing differentiated clinical data. “We will put every effort into becoming the first global stem cell therapy that achieves commercial success by entering the U.S. and Japan, the world’s largest knee osteoarthritis markets,” he added.