A South Korean pharmaceutical company has filed an investigational new drug application (IND) for a Phase 2 study of an oral coronavirus drug with natural ingredients in Korea.
Nanum Herb dedicated to Korean traditional medicines, or oriental medicines, announced on Tuesday its clinical trial protocol for Nanum-101 was filed with Korea’s Ministry of Food and Drug Safety to evaluate the efficacy and dosage of natural extracts against Covid-19 in the human body.
Nanum-101 was developed based on a natural antiviral compound that was developed by state-funded Korea Institute of Oriental Medicine (KIOM) as part of government research projects for nine years.
The drug was already proven safe in animal toxicity studies, thus making it possible to skip a Phase 1 and move directly into a Phase 2 trial.
The company said Nanum-101 has been patented in many countries with clinical benefits demonstrated in the treatment of swine flu and influenza.
Nanum-101 could be available as the world’s first natural antiviral against Covid-19 if it meets Phase 2 endpoints with a condition for the submission of Phase 3 data under the ministry’s emergency use authorization, which was applied to the country’s first chemically synthesized Covid-19 cure Rekirona from Celltrion.
Nanum Herb said once the regulatory permission is granted, i-World Pharm, a co-sponsor of the clinical study, will be commissioned to roll out the product. I-World Pharm runs KGMP facilities to produce both western and herbal medicines.
By Lee Chang-hoon and Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]