Daewoong's Covid treatment approved for Phase 1 trials

Daewoong Pharmaceutical's headquarters in Gangnam District, southern Seoul. [DAEWOONG PHARMACEUTICAL]

Daewoong Pharmaceutical’s Covid-19 drug candidate has won approval to undergo Phase 1 clinical trials in Korea, the company said Monday.

Upon authorization from the Ministry of Food and Drug Safety, the trial will be conducted on healthy people to test safety and monitor the patients' blood content after injection. Injections will start this month, the company said. Each patient will receive the dosage once.

Daewoong’s Covid-19 treatment candidate DWRX2003, or niclosamide, is currently undergoing Phase 1 trials in India and the Philippines, where the company had received nods earlier, in August and September. In India, a second round of tests are currently ongoing after a successful first that confirmed the substance’s safety, Daewoong said. The substance is also going through the first round of tests in the Philippines.

“Phase 1 clinical trial results will be used as the base to enter Phase 2 and Phase 3 clinical trials in a wider range of countries this year,” the pharmaceutical firm said in a Monday statement. “Our plan is to request an emergency use authorization as soon as we have the Phase 2 clinical trial results.”

DWRX2003 has a mechanism to suppress the growth of the coronavirus by activating the self-propelled behavior of human cells. The company had confirmed its efficacy via animal tests earlier on, and found the substance had the effect of reducing the virus’s activity in lung tissue and nasal discharge during Covid-19 infections.

“We will focus all of our capacity on obtaining Phase 1 clinical trials and prepare for Phase 2 and 3 tests to develop a Covid-19 treatment as soon as possible,” said Daewoong Pharmaceutical CEO Jeon Seng-ho.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]