Medipost's 'SMUP-IA-01' Phase 1 Clinical Trial Results Recognized by FDA

Exterior view of Medipost headquarters in Pangyo, Seongnam-si, Gyeonggi Province (Photo by Medipost)

[Asia Economy Reporter Chunhee Lee] Medipost announced on the 1st that it received a response from the U.S. Food and Drug Administration (FDA) recognizing the domestic Phase 1 clinical data of the injectable knee osteoarthritis treatment 'SMUP-IA-01,' allowing the company to skip Phase 1 and proceed directly to Phase 2.

Following the pre-Investigational New Drug (IND) consultation with the FDA, Medipost received this response, enabling the progression to Phase 2 despite being an allogeneic stem cell therapy, thereby reducing clinical costs and time. This is the second achievement following Cartistem, which was allowed to skip Phase 2 and proceed directly to Phase 3 in the U.S.

Along with the acquisition of a North American cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) company and successful large-scale investment attraction aimed at advancing U.S. clinical trials, this achievement is expected to accelerate the planned U.S. market entry of Cartistem and SMUP-IA-01. In addition, 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, and 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, “Our strategy to enter the global market based on excellent clinical results verified domestically will ultimately enhance the value of our pipeline as well as increase the likelihood of commercial success. We will do our best to become the first globally commercially successful stem cell therapy by entering the U.S. and Japanese markets, which are the largest knee osteoarthritis markets in the world.”

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