Medipost Initiates Phase 2 Clinical Trial for Osteoarthritis Treatment 'SMUP-IA-01'
[Asia Economy Reporter Lee Chun-hee] Medipost has begun Phase 2 clinical trials for its injectable knee osteoarthritis treatment 'SMUP-IA-01'.
Medipost announced on the 14th that the first patient dosing of SMUP-IA-01, which received Phase 2 clinical trial approval from the Ministry of Food and Drug Safety last October, has been conducted. The first dosing started at Seoul National University Hospital, and will be followed by dosing at four other institutions: Sinchon Severance Hospital, Bundang Seoul National University Hospital, Korea University Anam Hospital, and Asan Medical Center, totaling five institutions.
The domestic Phase 2 clinical trial of SMUP-IA-01 involves a total of 90 patients with mild to moderate knee osteoarthritis (K&L grade 2-3), divided into three groups: low dose, medium dose, and active control. After a single injection of the drug, safety and exploratory efficacy will be evaluated over a one-year observation period, and the optimal dose for Phase 3 clinical trials will also be determined.
In the previously conducted domestic Phase 1 clinical trial, 12 knee osteoarthritis patients at Seoul National University Hospital received a single intra-articular injection of the drug, followed by a six-month evaluation, confirming safety as well as improvements in joint function and pain.
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A Medipost representative stated, “Although there were difficulties in conducting the clinical trial due to COVID-19, we will proceed with the trial as smoothly as possible starting with this first patient dosing. We hope to contribute to improving the quality of life for osteoarthritis patients as soon as possible.”
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