Published 01 Apr.2022 11:29(KST)
[Asia Economy Reporter Hyungsoo Park] A green light has been given for the global clinical trials of Medipost's knee osteoarthritis treatment lineup.
Medipost announced on the 1st that it received recognition from the U.S. FDA for the Phase 1 clinical data of the injectable knee osteoarthritis treatment SMUP-IA-01 conducted in Korea, allowing the company to skip Phase 1 and proceed directly to Phase 2.
As a result of the Pre-IND meeting with the U.S. FDA, despite being an allogeneic stem cell therapy, proceeding to Phase 2 became possible, reducing clinical costs and time. This is the second achievement following Cartistem, which was able to skip Phase 2 and advance directly to Phase 3 in the U.S.
Last month, Medipost successfully acquired a North America-based cell and gene therapy CDMO company and secured large-scale investment for advancing U.S. clinical trials. It is expected to accelerate the U.S. market entry of Cartistem and SMUP-IA-01 as planned.
In Japan, the Phase 2 clinical trial of Cartistem combined with high tibial osteotomy (HTO), which had been temporarily suspended due to COVID-19, has resumed. Furthermore, the Phase 3 clinical trial of Cartistem as a standalone treatment has also commenced, marking the full-scale entry into the Japanese market.
A Medipost official stated, "The strategy of entering overseas markets based on excellent clinical results verified domestically can increase the possibility of commercial success." He added, "We will strive to become the first globally successful commercial stem cell therapy by entering the U.S. and Japanese markets, the world's largest knee osteoarthritis markets."