Zenesel Applies for Phase 2b/3 Clinical Trial of Oral COVID-19 Treatment

[Asia Economy Reporter Hyungsoo Park] Genencell announced on the 12th that it has recently applied to the Ministry of Food and Drug Safety for approval of the domestic Phase 2b/3 clinical trial plan (IND) for its oral COVID-19 treatment candidate, ‘ES16001’.

Genencell is currently preparing for global clinical trials of ‘ES16001’, centered in the European Union. ES16001 is a COVID-19 treatment candidate based on a novel material extracted from the leaves of the native Korean plant, Dambalsu, and confirmed exploratory efficacy through a Phase 2 clinical trial conducted in India last year.

The clinical trial will focus on preventing the progression to severe disease in early infected patients, thereby reducing hospitalization and mortality rates, and enabling treatment during asymptomatic stages. ES16001 was developed as a treatment for shingles through a national project by the Ministry of Agriculture, Food and Rural Affairs at Kyung Hee University Biomedical Research Center.

One of the multiple active components, ‘Geraniin’, 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 the causative virus ‘SARS-CoV2’ in COVID-19 and alleviate symptoms.

Compared to the COVID-19 treatment ‘Molnupiravir’ developed by MSD (Merck) in the United States, while both ultimately inhibit replication of the COVID-19 virus, Molnupiravir induces viral death by causing errors in the viral RNA sequence. Both are oral formulations targeting mild to moderate patients, and both plan to expand indications to include prevention as well as treatment.

On the other hand, ES16001 is based on natural raw materials, enabling multi-target therapy. Therefore, Genencell predicts it will be effective against variant viruses as well. It is superior in terms of long-term safety for continuous use, and the drug price is expected to be lower than that of Molnupiravir.

Professor Kang Se-chan of Kyung Hee University’s College of Life Sciences, who developed ES16001, stated, "Once the clinical plan is approved, we will proceed with patient recruitment and administration immediately and promptly apply for global clinical trials in European countries to secure clinical results as soon as possible."

He added, "We will gain a competitive advantage by launching at a significantly lower price compared to oral treatments developed overseas."

Professor Kang also emphasized, "By commercializing an oral COVID-19 treatment without side effects, we will accelerate clinical trials to enable our citizens to return to a safe and healthy life faster than any other country in the world."

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