S. Korea approves phase 2, 3 trials of Genencell’s COVID-19 treatment

South Korean biotech firm Genencell said Wednesday that the company received approval from the Ministry of Food and Drug Safety for mid- and late-stage trials of its COVID-19 treatment candidate ES16001.

ES16001 is an oral COVID-19 drug candidate made with natural ingredients extracted from the leaves of Elaeocarpus sylvestris native to Korea. Genencell has developed the treatment candidate in collaboration with the College of Life Sciences at Kyung Hee University.

Genencell currently plans to conduct clinical trials over 1,100 participants in five countries, including South Korea, India and three European countries to see safety and efficacy of the drug candidate.

The company said it plans to submit clinical trial applications in European countries within this year.

During its clinical trials, Genencell will test if the therapy is able to help lower hospitalization and mortality rates in patients.

Genencell expects ES16001 to effectively reduce binding activity of the coronavirus by suppressing the receptor-binding domain. The company said the novel drug alleviates COVID-19 symptoms as well.

Meanwhile, Korea Pharma will be responsible for manufacturing the COVID-19 treatment candidate that will be used in clinical trials.

By Shim Woo-hyun (ws@heraldcorp.com)