Genencell said Tuesday that it asked the Ministry of Food and Drug Safety to authorize phase 2 and 3 clinical trials of ES16001, the company’s oral Covid-19 therapy. 

The company expects the domestic study to serve as a starting point for its global clinical trials of ES16001 in European countries.

ES16001 is a novel Covid-19 treatment candidate extracted from the leaves of Elaeocarpus sylvestris var. ellipticus, also known as Dampalsu trees native to Korea. The material showed exploratory efficacy outcomes in phase 2 clinical trials conducted in India last year.

The company will focus on lowering hospitalization and mortality rates by preventing patients from progressing to severe conditions and being treated in an asymptomatic state in the clinical trial.

The company’s oral Covid-19 drug candidate includes an active ingredient, geraniin, which inhibits viral infection, and replication, suppressing host cell invasion and reactivation.

Genencell expects ES16001 to suppress the receptor-binding domain’ (RBD) binding activity of SARS-CoV2 and alleviate symptoms in Covid-19 patients.

ES16001 works similarly to MSD’s Covid-19 therapy molnupiravir, blocking the replication of the Covid-19 virus, but shows a difference in that molnupiravir induces errors in the viral RNA sequence, stopping the viral replication.

As ES16001 is based on natural ingredients, it allows patients to receive multi-target treatment, which Genencell believes to be effective against variants. As a result, the company expects the drug price of ES16001 could be much lower than molnupiravir, with excellent safety even in long-term administration.

“As soon as the clinical trial wins approval, we will begin recruiting patients, administer the drug candidate, and apply for global clinical trials in European countries,” said Professor Kang Se-chan of the College of Life Sciences at Kyung Hee University, who has developed ES16001. “Our candidate will be competitive with a significantly lower drug price than oral treatments developed overseas.”

Kang added that the research team would speed up the clinical trials to commercialize an oral Covid-19 treatment without side effects so that Koreans can return to a safe and healthy life faster than any other country in the world.