Genencell said that the Ministry of Food and Drug Safety has approved the company’s investigational new drug (IND) application to conduct phase 2 and 3 clinical trials for ES16001, an oral Covid-19 treatment.

Genencell explained that the ministry’s approval signals the official start of global clinical trials for its oral Covid-19 treatment.

The company plans to conduct its global clinical trial in Korea and eight countries, including India, and will verify the dose and efficacy of ES16001 in a total of 1,100 people.

Genencell stressed that the clinical focus would be on reducing the hospitalization and mortality rates by preventing the severe progression of patients with early infection and achieving a full cure from patients suffering from mild conditions.

“As the company has confirmed the safety and efficacy in preclinical studies, local phase 1 clinical trial, and India phase 2a trial, the company expects to produce positive results in phase 2 and 3 clinical trials as well,” Genencell Co-CEO Jung Yong-joon said. “Following Korea, we will also apply for clinical trials in Europe and India within this year.”

ES16001 is a new material-based new drug candidate extracted from the leaves of wild dampalsu trees, a native plant in Korea, developed jointly by Genencell and Kyunghee University’s Biomedical Research Institute.

ES16001 has a mechanism of inhibiting virus infection and replication and inhibiting host cell invasion and reactivation. Therefore, the company expects that the treatment candidate will inhibit the receptor-binding domain binding activity of SARS-CoV2, the virus that causes Covid-19 and alleviate symptoms.

Also, as ES16001 is a natural product, it is expected to respond to variants and can become a multi-target treatment, the company added.