Daewoong Pharmaceutical gained the Ministry of Food and Drug Safety’s approval to conduct a phase 1 clinical trial of niclosamide as a potential COVID-19 treatment, the company said Monday.

Daewoong is currently testing its niclosamide pipeline DWRX2003 in India and Philippines, where the company says the progress is smooth.

Daewoong plans to enter phase 2/3 trial in multiple nations before this year ends, and aims to apply for conditional approval or emergency use of the drug upon phase 2 clinical trial results.

In Korea, the clinical phase 1 trial, targeting healthy people, will take place at Chungnam National University Hospital starting October. The trial will ascertain the safe and efficacious dosage of the niclosamide through randomized, double-blind comparison with placebo.

Daewoong believes niclosamide not only has antiviral effects for COVID-19 but also has the ability to suppress other complications in seriously afflicted COVID-19 patients -- as well as prevent deaths resulting from “twindemic” infections with seasonal influenza. 

By Lim Jeong-yeo (kaylalim@heraldcorp.com)