[천지일보=홍보영 기자] Chong Kun Dang announced on the 8th that it applied to the Ministry of Food and Drug Safety for conditional approval and phase 3 clinical approval of’Napabeltan (ingredient name Napamostat)’ as a treatment for Corona 19 for severely high-risk patients.
Chong Kun Dang randomly assigned 104 severely high-risk patients to the Napabeltan-treated group and the standard treatment group in the Phase 2 clinical trial conducted in Russia last year, administered them for 10 days, and analyzed the results of 36 high-risk groups with an early warning score (NEWS) of 7 or more. It was confirmed that the p-value of phosphorus was 0.012, which reliably reached the target of 0.05 or less.
In the napabeltan 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 group and 61.1 of the standard treatment group. Percent of patients recovered and also showed statistically significant results.
In particular, four cases of death due to worsening symptoms of Corona 19 occurred in the standard treatment group, but not in the Napabeltan-treated group, confirming the possibility of Napabeltan as a drug that prevents the death of high-risk patients.
Chong Kun Dang said that it is in consultation with a number of countries such as the UK, France, Japan, and Russia to supply Napa Beltan based on the results of phase 2 clinical trials on the effect of COVID-19 treatment. This application for permission is to secure a clear basis for approval for overseas emergency use, enabling rapid export of the domestic Corona 19 treatment.
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 target about 600 severely high-risk patients, and are conducted in more than 10 institutions including Seoul National University Hospital in Korea, and global clinical trials will also be promoted to promptly recruit clinical patients.
An official from Chong Kun Dang said, “Napabeltan is the only drug that has reliably proved its therapeutic effect in the absence of a cure for COVID-19 for severely high-risk patients.” “In particular, it can be applied to various mutant viruses, preventing re-proliferation of Corona 19 due to mutation. It will greatly contribute to this.
Chong Kun Dang’s approval of phase 2 clinical trials in Russia in August last year, and its application for conditional approval was supported by active support from the Ministry of Science and ICT, the Ministry of Health and Welfare, the Ministry of Food and Drug Safety and the National Clinical Trial Support Foundation.
Currently, Chong Kun Dang is participating in the global clinical trial project ASCOT clinical trial in Australia, New Zealand and India, and is conducting phase 2 clinical trials in Mexico and Senegal as well.
‘;
Copyright © Cheonji Ilbo-Unauthorized reproduction and redistribution of the press release of hope for a new era is prohibited.