ZennCell Receives IND Approval for Phase 2 and 3 COVID-19 Treatment Trials in India... Global Clinical Studies Begin

[Asia Economy Reporter Lee Gwan-joo] Genensel announced on the 2nd that it has received approval for the Phase 2 and 3 clinical trial plan (IND) for the oral COVID-19 treatment 'ES16001' from the Indian Drug Controller General of India (DCGI).

Genensel is currently conducting clinical trials for the COVID-19 treatment in a multinational format (global clinical trials). Following the approval of the clinical trial plan in India after domestic approval last October, the development is expected to accelerate. Multinational clinical trials targeting Europe, Russia, and other regions are planned, so the Indian clinical trials will also be conducted in accordance with the relatively strict standards of the Korean Ministry of Food and Drug Safety and the European Medicines Agency (EMA).

Before this IND approval, Genensel had already secured 20 clinical hospitals in India, and among them, 9 hospitals have passed the Institutional Review Board (IRB) review. Patient recruitment will begin immediately centered on these hospitals. The clinical trial drugs will be manufactured under consignment by Korea Pharma, Genensel’s strategic partner.

A Genensel official stated, “Since some efficacy was already confirmed through Ayurveda (traditional medicine) clinical trials in India in 2020, positive results are expected in this clinical trial as well.”

Meanwhile, Genensel recently conducted molecular docking analysis experiments on the potential of the main component of ES16001 to treat COVID-19 Omicron subvariants (BA.4 and BA.5) in collaboration with Professor Kang Se-chan’s research team at Kyung Hee University’s School of Biotechnology and Professor Kim Hyung-gun’s research team at Sungkyunkwan University’s Department of Biomechatronics, producing positive results.

In particular, the average binding energy between Geraniin, the main component of ES16001, and the Omicron subvariant virus RBD (host cell receptor binding domain) was -11.7 kcal/mol, which was higher than the average binding energy of -9.4 kcal/mol for the original virus.

ES16001 is a new drug candidate based on a novel material extracted from the leaves of the domestically native plant, Daphalsu.

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