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Institut Pasteur Korea and Daewoong Holdings are in preparation of clinical trial of niclosamide to treat COVID-19
April 14, 2020

Institut Pasteur Korea and Daewoong Holdings are in preparation of clinical trial of niclosamide to treat COVID-19

- Daewoong Therapeutics, a subsidiary of Daewoong Holdings, will maximize the antiviral efficacy through its drug delivery system technology and prepare clinical trial to begin in July -
 
Institut Pasteur Korea and Daewoong Holdings have initiated a collaboration in research and development of COVID-19 treatment. Daewoong Therapeutics and Daewoong Pharmaceutical, the subsidiaries of Daewoong Holdings, are preparing to enter a clinical trial of niclosamide, a drug confirmed by Institut Pasteur Korea to have excellent antiviral efficacy against COVID-19.

According to the results of the drug-repositioning research perused by Institut Pasteur Korea, the antiviral efficacy of niclosamide (parasiticide) against COVID-19 in cell experiments was superior to the drugs currently under clinical trials at home and abroad; Specifically, 40 times higher than the remdesivir (Ebola treatment) and 26 times higher than the chloroquine (malaria treatment)*. The research was conducted as a part of the National Life and Safety Emergency Response Research funded by the Ministry of Science and ICT. (* Source: Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs / Mar 20, 2020).

Despite its excellent antiviral effect on COVID-19, niclosamide had a problem of maintaining blood drug concentrations in the human body when taken orally, making it difficult to be applied as an actual treatment for COVID-19.

Daewoong Therapeutics is an R&D specialized company that maximizes drug effects, improves side effects, and increase ease of use, by leveraging its drug delivery technology. After successfully developing a new formulation 'DWRX2003' in 2019 that maintains blood concentration of niclosamide, Daewoong Therapeutics has been developing it into a treatment for refractory lung disease in collaboration with 'Knotus', the largest non-clinical research institute in Korea. Earlier this year, ‘DWRX2003’, as a treatment for intractable lung disease, was confirmed in animal experiments to improve respiratory distress through inhibition of lung tissue mucus secretion, and to inhibit cytokine storm through suppression of inflammatory cell infiltration.

Niclosamide is a component of ‘DWRX2003’. Based on the research results of Institut Pasteur Korea, Daewoong Therapeutics decided to develop 'DWRX2003' to COVID-19 treatment concurrently. The efficacy test in primate experiments to be led by Daewoong Pharmaceutical and Korea Research Institute of Bioscience and Biotechnology is being planned in May, and then the application for a clinical trial will be submitted to the Ministry of Food and Drug Safety in July.

According to the recent research published in Nature Communications, German researchers found that niclosamide inhibits the proliferation of viruses by activating autophagy in cells. Unlike remdesivir, which is known to act on the virus and inhibit RNA genomic synthesis, niclosamide acts on the cells. Therefore, it is less likely to develop resistance.

Dr. Wang-Shick Ryu, CEO of Institut Pasteur Korea, said, "Developing niclosamide towards a COVID-19 treatment is a good example of drug-repositioning research where the research capabilities of Institut Pasteur Korea and the development technology of Daewoong Therapeutics are strategically combined.", and added, “We hope the further development to be successful and to help to end the COVID-19 pandemic."

Minsuk Lee, CEO of Daewong Therapeutics, said, “’DWRX2003', as proven to be effective on COVID-19 in the research of Institut Pasteur Korea, we plan to promptly develop it into a COVID-19 treatment as well as into refractory lung disease treatment.” He added, “’DWRX2003’ is expected not only to have an antiviral effect but also to have a high possibility of suppressing complications in lung tissue in severely infected patients."


Sengho Jeon, CEO of Daewoong Pharmaceutical, said, “Daewoong Pharmaceutical will collaborate with Daewoong Therapeutics in development of COVID-19 treatment and promote close cooperation with government-funded research institutes such as Institut Pasteur Korea.”, and added, "We will provide active support to help the results to be generated quickly."