[서울=뉴스프리존]Reporter Park Jin-young = On the 8th, Chong Kun Dang applied for conditional approval and phase 3 clinical approval of’Napabeltan’ (ingredient name Napamostat) as a COVID-19 treatment for severely high-risk patients to the Ministry of Food and Drug Safety.
Last year, the drug conducted phase 2 clinical trials in 104 severely ill patients with COVID-19 in Russia, proving that it prevents worsening of symptoms and improves treatment duration and treatment rate in severely high-risk patients caused by COVID-19. It has also been confirmed that the treatment mechanism is applied to the mutation of the virus found abroad.
Chong Kun Dang randomly assigned 104 patients in the severely high-risk group to the Napabeltan-treated group and the standard treatment group in phase 2 clinical trials, administered them for 10 days, and analyzed the results of 36 high-risk groups with a National Early Warning Score (NEWS) of 7 or more. It was confirmed that the p-value, an index of statistical significance, reached 0.012, which was clearly reaching the target of 0.05 or less.
In the napabeltan-treated group, 61.1% of patients reached recovery immediately after 10 days of administration, showing a superior effect compared to 11.1% of the standard treatment group.After 28 days of the total clinical period, 94.4% of the napabeltan-treated group, and the standard treatment group. 61.1% of patients recovered, showing statistically significant results.
Four cases of death due to worsening symptoms of Corona 19 occurred in the standard treatment group, but not in the Napabeltan-treated group.
Based on the results of Phase 2, Chong Kun Dang is in negotiations with a number of countries including the UK, France, Japan, and Russia to supply Napa Beltan. This application for permission is to secure clear grounds necessary for approval for overseas emergency use so that the rapid export of domestic Corona 19 therapeutics is possible.
Chong Kun Dang submitted a large-scale phase 3 clinical trial plan along with the application for conditional approval from Napa Beltan. Phase 3 clinical trials are conducted at more than 10 institutions including Seoul National University Hospital in Korea, targeting about 600 severely high-risk patients, and a global clinical trial will also be promoted for rapid recruitment of clinical patients.
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