ZennCell Receives Approval for Phase 2 and 3 Clinical Trials of Oral COVID-19 Treatment

Genensel Logo (Photo by Genensel)

[Asia Economy Reporter Lee Chun-hee] The oral COVID-19 treatment 'ES16001' developed by Genencell has received approval for its Phase 2/3 clinical trial plan (IND) in South Korea.

Genencell announced on the 27th that its Phase 2/3 clinical trial plan for the COVID-19 treatment 'ES16001' was approved by the Ministry of Food and Drug Safety on the 26th.

This clinical trial will be conducted globally, involving over 1,100 participants across five countries including South Korea, three European countries, and India, to verify the dosage and efficacy of ES16001. The focus is particularly on preventing the progression to severe disease in early infected patients, thereby reducing hospitalization and mortality rates, and achieving full recovery from mild conditions.

ES16001 is a new drug candidate based on a novel material extracted from the leaves of the domestically native plant, Dampaulsu. Genencell co-developed it with Kyung Hee University Biomedical Research Center. It has a mechanism that inhibits viral infection and replication, as well as suppresses host cell invasion and reactivation, which is expected to inhibit the binding activity of the COVID-19 virus's RBD (receptor-binding domain) and alleviate symptoms.

Jung Yong-jun, co-CEO of Genencell, said, “Since safety and some efficacy have already been confirmed in preclinical studies, domestic Phase 1 trials, and clinical trials in India, positive results are expected in this trial as well,” adding, “Following South Korea, we will proceed with the clinical trial application procedures in Europe and India within this year.”