APRG applies for domestic Phase 2a clinical trial of COVID-19 treatment 'APRG64'
[Asia Economy Reporter Lee Gwanju] APRG, a company specializing in infectious disease drug development, announced on the 22nd that it has applied to the Ministry of Food and Drug Safety for approval of the clinical trial plan (IND) for the oral COVID-19 treatment 'APRG64' Phase 2a clinical trial in South Korea.
This clinical trial will target 90 patients with mild to moderate COVID-19, aiming to verify the exploratory efficacy of APRG64 in reducing the progression to severe disease and mortality rates.
The candidate substance APRG64 is a mixed extract of Yongacho (Seonhakcho) and Obaeja, developed through joint research with Kyung Hee University Biomedical Research Center. It is expected to inhibit viral cell entry and replication and improve immunity.
Additionally, APRG recently completed a lease contract for a Yongacho cultivation complex of approximately 100,000㎡ in Yeoju-si, Gyeonggi Province, and is producing seedlings through seed germination and tissue culture. Yongacho has mainly been imported from China, but with this clinical trial as a turning point, APRG plans to localize the medicinal crop by establishing a smart farm in collaboration with Professor Lee Chanhee's research team (Plant Molecular Biology) at Kyung Hee University and Professor Kim Sunhyung's research team (Plant Genetic Engineering) at the University of Seoul, and to produce high-quality raw materials for therapeutics starting in the second half of the year.
Earlier this month, APRG received approval for a Phase 2 clinical trial of an Ayurveda (natural medicine) with the same indication in India and is preparing for patient administration.
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Choi Soonho, CEO of APRG, explained, "Our goal is to successfully complete this domestic clinical trial and proceed with the subsequent Phase 2b and 3 clinical trials within the year," adding, "We are establishing a raw material cultivation complex for APRG64 to facilitate full-scale commercialization after the clinical trials."
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