APRJ Applies for Phase 2a Clinical Trial of COVID-19 Treatment

Published 22 Feb.2022 11:56(KST)

[Asia Economy Reporter Hyungsoo Park] APRG, a developer of infectious disease therapeutics, announced on the 22nd that it has applied to the Ministry of Food and Drug Safety for approval of the domestic Phase 2a clinical trial plan (IND) for the oral COVID-19 treatment ‘APRG64’.

The trial will be conducted on 90 patients with mild to moderate COVID-19. It aims 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 jointly with Kyung Hee University Biomedical Research Center. It is expected to inhibit viral intracellular penetration and replication, as well as improve immunity.

Recently, APRG received approval for a Phase 2 clinical trial of the same indication for an Ayurvedic (natural medicine) product in India. The company has completed a lease contract for a Yongacho cultivation site of about 100,000㎡ (approximately 30,000 pyeong) in Yeoju, Gyeonggi Province, and is producing seedlings through seed germination and tissue culture.

Yongacho was mainly imported from China, but APRG plans to localize it by building a smart farm for medicinal crops in collaboration with Professor Chanhee Lee’s research team (Plant Molecular Biology) at Kyung Hee University and Professor Sunhyung Kim’s research team (Plant Genetic Engineering) at the University of Seoul, using the clinical trial as an opportunity. They expect to produce high-quality raw materials for therapeutics starting in the second half of this year.

Choi Soonho, CEO of APRG, explained, "Our goal is to proceed with Phase 2b/3 clinical trials within this year," adding, "We are establishing a raw material cultivation site for ‘APRG64’ to facilitate full-scale commercialization after the clinical trials."