APRJ, Phase 1 Clinical Trial of Oral COVID-19 Treatment in India

[Asia Economy Reporter Hyungsoo Park] Gold Pacific announced on the 29th that its subsidiary APRG has been notified by the Central Drugs Standard Control Organization (CDSCO) of India about the completion results of Phase 1 clinical trials for the oral COVID-19 treatment candidate 'APRG64'.

The Phase 1 clinical trial in India, conducted in collaboration with Professor Sechan Kang's research team at Kyung Hee University Biomedical Research Center (BMRI), focused on pharmacokinetics and safety evaluation to understand "how the drug changes in the body due to internal factors."

According to APRG, the Phase 1 clinical trial was conducted in India on 40 healthy adults using APRG64. The clinical trial involved single and multiple doses across three dosage groups, verifying tolerability and safety without any adverse reactions in all participants.

APRG plans to simultaneously conduct Phase 2 clinical trials in Korea, Australia, and India, officially launching global clinical trials. The Phase 2 trials, targeting mild to moderate patients, aim to be completed by 2022.

Oh Byungseop, Chief Strategy Officer (CSO) of APRG, stated, "With the approval of the Phase 1 clinical trial in India as a milestone, we plan to accelerate clinical trials of APRG64 for COVID-19 in major countries and pursue entry into overseas markets." He added, "The consortium, led by Kyung Hee University Industry-Academic Cooperation Foundation, will have the Korea Institute of Drug Safety & Risk Management (KIDS) conduct contract research organization (CRO) services, and Korea Pharma will handle drug manufacturing," and "the full cycle of new drug development has been completed."

APRG has verified the influenza infection prevention and treatment effects of APRG64 through cell and animal experiments and has completed patent applications. APRG explained that these meaningful results demonstrate the potential for APRG64 to be developed as an oral treatment for viral respiratory diseases during the transition to With-Corona.

This content was produced with the assistance of AI translation services.