ZennCell Begins Global Clinical Trials for Oral COVID-19 Treatment... IND Applications in Europe and India Within the Year

[Asia Economy Reporter Hyungsoo Park] Genencell announced on the 27th that it received approval from the Ministry of Food and Drug Safety on the 26th for the domestic Phase 2/3 clinical trial plan (IND) of the oral COVID-19 treatment ‘ES16001’.

Genencell explained that this signifies the official start of the global clinical trial for the COVID-19 treatment. The global trial will be conducted in five countries including South Korea, three European countries, and India, involving approximately 1,100 participants to verify the dosage and efficacy of ‘ES16001’.

The clinical trial will focus 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 native Korean plant, Dambalsu, jointly developed by Genencell and Kyung Hee University Biomedical Research Center.

‘ES16001’ has a mechanism that inhibits viral infection and replication, as well as suppresses host cell invasion and reactivation. It is expected to inhibit the binding activity of the RBD (receptor-binding domain) of ‘SARS-CoV2’, the virus causing COVID-19, and alleviate symptoms.

Additionally, as ‘ES16001’ is based on natural substances, it allows for multi-target treatment, making it effective against variant viruses. Compared to oral treatments currently under development overseas, it is expected to have fewer side effects and significantly lower costs.

Jongjun Jung, Co-CEO of Genencell and head of the clinical trial, stated, "Having confirmed safety and some efficacy in preclinical studies, domestic Phase 1 trials, and Indian trials, we expect positive results in this clinical trial as well," adding, "We will proceed with the clinical trial application procedures in Europe and India within this year following South Korea."

Genencell is known to have secured stable clinical funding by attracting investment from Sejong Medical, a strategic investor (SI) and the largest shareholder. Furthermore, the clinical trial drugs will be produced by Korea Pharma, another strategic investor of Genencell, and the CRO (Contract Research Organization) will be managed by the Korea Institute of Drug Development.