APRG Receives Domestic Phase 2a Approval for Oral COVID-19 Treatment 'APRG64'

[Asia Economy Reporter Lee Chun-hee] APRG, an affiliate of Genensel, announced on the 13th that it has received approval from the Ministry of Food and Drug Safety for the clinical trial plan (IND) for the domestic Phase 2a clinical trial of 'APRG64,' an oral COVID-19 treatment under development.

APRG64 is a mixed extract of Yongacho and Obaeja, containing various active ingredients such as Quercetin, Ursolic acid, and Pentagalloyl glucose (PGG). It works by inhibiting the binding activity of the receptor-binding domain (RBD) of the virus-host cell receptor of SARS-CoV-2, the virus that causes COVID-19.

Currently, APRG64 is also in Phase 2a clinical trials in India, with 45 patients enrolled and receiving treatment. In Korea, safety and exploratory efficacy will be evaluated in 90 patients with mild to moderate symptoms.

Oh Byung-seop, Vice President of APRG, stated, “We will do our best to develop a treatment that has no side effects, is easy to take, and is competitively priced so that it can be used even after COVID-19 becomes endemic.”

Meanwhile, Genensel is continuing clinical trials for 'ES16001,' another COVID-19 treatment under development. The multinational Phase 2 trial is underway, involving about 100 patients in Korea and 300 in India, totaling 400 participants. The study uses a placebo-controlled, double-blind design to verify dosage and exploratory efficacy. After completing Phase 2, a multinational Phase 3 trial targeting about 700 participants is planned.

Lee Sung-ho, CEO of Genensel, recently commented on the endemic phase of COVID-19, saying, “After completing Phase 2, we plan to seek emergency use authorization or conditional approval,” and added, “Since we have sufficient market competitiveness, we will complete development to the end.”

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