Analysis of Clinical Outcomes After 1-Year Observation Based on a Reader-Developed Stem Cell Culture Platform
[Asia Economy Reporter Lee Gwan-joo] Medipost announced on the 12th that it has completed patient dosing for the domestic Phase 2 clinical trial of the injectable knee osteoarthritis treatment 'SMUP-IA-01.'
SMUP-IA-01 is an injectable knee osteoarthritis treatment developed using Medipost's proprietary stem cell culture platform technology called 'SMUP-Cell.'
The domestic Phase 2 clinical trial began dosing the first patient in March of this year and was conducted at five institutions: Seoul National University Hospital, Severance Hospital, Bundang Seoul National University Hospital, Korea University Anam Hospital, and Gangnam Severance Hospital. A total of 93 patients with mild to moderate knee osteoarthritis were divided into three groups?low dose, medium dose, and active control?and received a single dose of the drug. Safety and exploratory efficacy will be evaluated during a one-year observation period after dosing, and the optimal dose for Phase 3 clinical trials will be determined.
A Medipost official stated, “Despite the challenging environment for clinical trials due to the resurgence of COVID-19, patient dosing progressed rapidly thanks to the active cooperation of clinical staff and patients. After the one-year observation period ends, we plan to promptly advance to the next phase of clinical trials and commercialization based on the analysis of clinical results, aiming to establish SMUP-IA-01 as a leading brand for knee osteoarthritis treatments alongside Cartistem.”
Meanwhile, Medipost plans to proceed with the U.S. Phase 2 clinical trial after receiving confirmation from the U.S. Food and Drug Administration (FDA) that the domestic clinical data for SMUP-IA-01 is recognized, allowing them to skip Phase 1 and proceed directly to Phase 2.
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