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

Daewoong Pharmaceutical obtains approval from South Korea for clinical trial of niclosamide, a treatment for COVID-19 - Development is accelerated after approval from South Korea on the 8th… Phase-1 clinical trials in India and Philippines are proceeding smoothly - Aims to progress into phase-2 and 3 clinical trials, and obtain conditional and emergency use permission on various countries based on phase-2 clinical trial results within the year - Death rate from the influenza virus, concerned to cause a “twindemic” along with COVID-19, displays 0%, and improvements on clinical signs are confirmed Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) and its subsidiary Daewoong Therapeutics (CEO Minsuk Lee) have obtained approval for phase-1 clinical trial of DWRX2003 (active ingredient: niclosamide), a treatment for COVID-19, from the Ministry of Food and Drug Safety on the 8th. This clinical trial is to be proceeded at Chungnam National University Hospital targeting healthy subjects, and will begin injection on October. The test is randomized, double-blinded, placebo-controlled, and of single-dose, evaluating the safety and the maintenance of the medicine’s concentrations in the blood. Furthermore, Daewoong is carrying out phase-1 clinical trials in not only South Korea but also India and Philippines, accelerating its global development. In India, phase-1 clinical trial targeting healthy volunteers is ongoing, verifying safety on the first injection group and proceeding to the next. In Philippines, phase-1 clinical trial targets COVID-19 patients, which is expected to investigate both its safety and its curative power. Daewoong is planning on entering phase-2 and 3 on various countries based on their phase-1 clinical trial results, and immediately applying for conditional and emergency use permission based on their phase-2 results within this year. Niclosamide is known to have a mechanism of blocking both penetration and discharge of a virus to human cells. DWRX2003 is niclosamide in 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 disease only with a single dose, and avoiding possible side effects of oral administration in the digestive system (e.g. nausea, vomiting). CEO Sengho Jeon at Daewoong said, “We will focus our full capabilities on accelerating clinical trials for development of a medicine for COVID-19 as soon as possible, by simultaneously securing phase-1 clinical trial results, preparing IND for phase-2 and 3, and more.” “Daewoong Pharmaceutical will strive for development of medicines, such as niclosamide and camostat, for COVID-19 patients all around the world while expanding its R&D towards infectious virus diseases,” he added. CEO Minsuk Lee at Daewoong Therapeutics said, “Niclosamide is also confirmed to be very effective to COVID-19, so we can expect not only antiviral effects but also the possibility of restraining complications on critically infected patients.” “By working together with Daewoong Pharmaceutical, we will do our best on various R&D on treatments that are effective for not only COVID-19 but also additional viral diseases,” he added. On the other hand, while patients infected with both COVID-19 and influenza virus are being reported, and concerns of a possible “twindemic” is consistently raised, Daewoong confirmed by animal testing that niclosamide decreased the death rate caused by the influenza. While 40% of placebo administration group died, the groups with niclosamide administered 12 hours before infection and 7 days after infection both showed a death rate of 0%. Especially, the group with niclosamide administered 7 days after infection, when the symptoms have worsened, has shown 75% of improvement 2 days after administration compared to the control group. # # #

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