South Korea’s Genencell has drawn spotlight with a progress in the novel development of a plant-based antiviral against the Omicron variant.
The company obtained a regulatory nod for local Phase 2 and 3 trials of ES16001, an oral Covid-19 drug candidate, at the end of October, and is preparing for site selection and institutional review board (IRB) review simultaneously.
It anticipates subject randomization early next year and Phase 2 completion in the third quarter of next year, Genencell founder Kang Se-chan, Professor of Dept. of Oriental Medicine Biotechnology, Kyung Hee University, told Maeil Business Newspaper in a recent interview.
ES16001, an extract of a local plant Elaeocarpus, which was repurposed from use to treat herpes zoster, was chosen from some 2,000 native plants believed to be antiviral and cost effective after a lab and preclinical tests.
ES16001 is expected to greatly contribute to the fight against the Omicron because it has a greater effect on viral mutation than existing viruses.
Genencell founder Kang Se-chan
ES16001 has a mechanism to inhibit viral activity by blocking the receptor-binding domain (RBD) of the coronavirus. In particular, `geraniin`, one of several active ingredients of the drug, inhibits virus infection and replication, while preventing virus invasion and activation in host cells, according to Prof. Kang.
Genencell is currently focusing on domestic and overseas clinical trials of ES16001. A Phase 2a study started with 60 subjects at an Indian hospital in September last year. Interim study results showed more than 95 percent of patients with mild to moderate Covid-19 recovered within 6 days of treatment, higher than 68 percent in the group treated with standard therapy alone.
The company is also working together with RDP Pharma, a virus research company located in Switzerland, in terms of clinical trials and licensing agreement. Genencell is preparing for clinical trials through OPIS, Europe`s largest full-service clinical trial contract organization. Prof. Kang said Genencell is ready for a pre-meeting with the European Medicines Agency (EMA) and is progressing submission to the agency.
Genencell aims to apply for emergency use authorization to the Ministry of Food and Drug Safety in Korea next year after Phase 2 clinical trials.
By Kim Si-gyun and Minu Kim
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