– Accelerated development with approval of clinical trials in Korea on the 8th… Phase 1 clinical trials of COVID-19 drug go smoothly in India and the Philippines
– Aim to apply for Accelerated Approval and Emergency Use Authorization after planning to enter multi-national Phase 2 and 3 clinical trials and securing results of Phase 2 clinical trials within this year
– Confirmed a mortality rate of 0% and the effect of improving clinical symptoms even in the influenza virus, which concerns to cause ‘twin-demic’ other than COVID-19
| Daewoong Pharmaceutical(CEO Sengho Jeon) and Daewoong Therapeutics(CEO Min-Seok Lee), a subsidiary of Daewoong Co., Ltd., announced the new coronavirus infection(COVID-19) treatment ‘DWRX2003(Niclosamide, the ingredient name)’ obtained approval for Phase 1 clinical trials in Korea from the Ministry of Food and Drug Safety (hereinafter MFDS) on the 8th. Daewoong Pharmaceutical is currently conducting clinical trials of the COVID-19 stem cell treatment ‘DWP710’ in Indonesia, and is conducting Phase 2 clinical trials of Camostat(Foistar), which is expected to show therapeutic effects on mild and moderate COVID-19 patients, in Korea and Mexico. Phase 1 clinical trials of “DWRX2003”(Niclosamide, the ingredient name) in Korea will be conducted at Chungnam National University Hospital on healthy subjects, and administration will begin in October. In clinical trials, Niclosamide or placebo will be randomly assigned, double-blinded, placebo-controlled, and administrated for a single time to confirm safety and maintenance of drug concentrations in the blood. Daewoong Pharmaceutical is also accelerating global development by carrying out the first phase of clinical trials for “DWRX2003” in India and the Philippines, including Korea. In India, Phase 1 clinical trials are in progress for healthy individuals, confirming safety in the first group of medications, and clinical trials for the second group are in progress smoothly. In the Philippines, it is predicted to simultaneously explore the safety and treatment effects by conducting Phase 1 clinical trials for COVID-19 patients. Daewoong Pharmaceutical plans to enter Phase 2 and 3 of multi-national clinical trials within this year based on the results of Phase 1 clinical trials, and will immediately apply for Accelerated Approval and Emergency Use Authorization once the results of Phase 2 are secured. Niclosamide is known as a mechanism drug that can inhibit both penetration and excretion of viruses into human cells. DWRX2003 is a product developed by Niclosamide as a sustained release injection using Daewoong Group’s proprietary drug delivery technology. △It overcomes the low absorption rate of oral administration. △ It is expected to maintain the concentration that can treat viral diseases only with a single administration. △It has the advantage of avoiding the side effects of the digestive system (nausea, vomiting, etc.) that occur when administered orally. Meanwhile, Daewoong Pharmaceutical also confirmed the effect of influenza-induced mortality in the animal efficacy test of ‘DWRX2003’, which is developed as a treatment for novel coronavirus infections. The animal testing was conducted due to the cases of simultaneous infection of COVID-19 and influenza, and the continuously raised concerns of ‘twin-demic’ around the world. The animal efficacy test for Niclosmaide confirmed that 40% of the placebo-dosing group died, while both 12 hours before and 7 days after the virus infection had a zero mortality rate. In particular, the clinical symptom score on the second day of administration showed an outstanding improvement of 75% compared to that of the control group even when the drug was administered after the clinical symptoms deteriorated on the 7th day of infection. “We will focus all our capabilities on accelerating clinical trials by preparing Phase 2 and Phase 3 IND while securing Phase 1 results so that we can develop COVID-19 treatments as soon as possible,” said Sengho Jeon, CEO of Daewoong Pharmaceutical. “We will strive to develop treatment such as Niclosamide and Camostat while expanding research and development for viral infectious diseases,” he added. “Niclosamide is an ingredient that has proven to have excellent effects on COVID-19, and we expect that there will be a high possibility of suppressing complications in patients with severe infections as well as anti-viral effects,” said Min-seok Lee, CEO of Daewoong Therapeutics. “We will work with Daewoong Pharmaceutical to do our best in various research and development to develop it as an effective treatment for additional viral infectious diseases,” he stated. |