Daewoong Pharmaceutical obtains approval from Australia for clinical trial of niclosamide, a treatment for COVID-19

Daewoong Pharmaceutical obtains approval from Australia for clinical trial of niclosamide, a treatment for COVID-19 - Global clinical trials are proceeding on track… Safety is confirmed from local injection results - Global COVID-19 treatment will be developed in earnest by securing clinical trial results from various developed countries including South Korea and various races Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced on the 19th that it has obtained approval from the Australian Therapeutic Goods Administration (TGA) on the 16th (local time) for phase-1 clinical trial of DWRX2003 (active ingredient: niclosamide), a treatment for COVID-19 in development. Hence, full-scale clinical trials will begin in November. This phase-1 clinical trial targeting about 30 healthy local subjects will confirm the safety and tolerability of the drug. The results in Australia will comprise data of Caucasians, which can play an important role in explaining differences between races and more when global clinical trials begin in the US, Europe, and more. DWRX2003 has a mechanism that blocks virus proliferation by activating cells’ autophagy. DWRX2003 containing niclosamide is a modified-release injectable form developed with Daewoong’s unique drug carrier technology, and has advantages such as overcoming low absorption rate of oral administration, being expected to maintain enough concentration for curing virus diseases with only a single dose, and avoiding possible side effects of oral administration in the digestive system (nausea, vomiting, etc.) In addition, vivo efficacy tests on animals have shown it to be effective against COVID-19 and influenza virus. In India where global clinical trials are already on-going, injection results of 1st and 2nd group of healthy subjects have confirmed the safety and tolerability of the drug among the participants. Once the safety among different races is confirmed from South Korea and Australia, both of which has approved the clinical trial recently, entering global phase-2 and 3 clinical trials will be accelerated by applying for phase-2 clinical tests on U.S. Food and Drug Administration (FDA) and pre-IND meeting. Furthermore, for providing the treatment to developed countries, technology transfer partnerships with candidate companies are under discussion. CEO Sengho Jeon at Daewoong said, “Clinical trial results of DWRX2003 in Australia is significant for DWRX2003 to advance to the market of developed countries, which makes this approval of clinical trials more meaningful.” He added, “We’re spurring on to get the injectable niclosamide ready for phase-2 and 3 clinical trials in not only South Korea, but also various developed countries, including the US and Europe.” CEO Minsuk Lee at Daewoong Therapeutics said, “DWRX2003 is confirmed to be effective against both COVID-19 and influenza virus by animal testing.” He added, “With cooperation from Daewoong, clinical trials for influenza is getting ready, and we’re planning on developing a medicine that can prepare for a twindemic.” # # #

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