Napabeltan, which Chong Kun Dang (CEO Kim Young-ju) is developing as a treatment for Corona 19, showed about 2.9 times higher treatment effect than the standard treatment group in high-risk patients.
On the 14th, Chong Kun Dang announced the results of phase 2 clinical trials in Russia for 100 severely ill patients with Corona 19, and said, “As a result of evaluating various clinical indicators, statistical significance was secured.”
Chong Kun Dang analyzed 36 high-risk patients with a National Early Warning Score (NEWS) of 7 or more by administering placebo and napabeltan to 100 confirmed patients with COVID-19 for 10 days in the Russian phase 2 clinical trial. It was announced that the p-value was 0.012, which clearly reached the verification target of 0.05 or less. The early warning score is an index that predicts the fatality of patients with pneumonia due to coronavirus, and it is known that patients with high risk groups with a score of 7 or more have an 18-fold increase in mortality.
Clinical results showed a 61.1% improvement in symptoms while napabeltan was administered in high-risk patients, which was clearly superior to 11.1% of standard treatment (p-value 0.002). The symptom improvement rate of the standard treatment group was 61.1% for the entire clinical period, 28 days, compared to 94.4% (p-value 0.016) in the Napabeltan group, which was almost perfect. Even in the period of reaching recovery, the Napabeltan-treated group reduced to 10 days compared to 14 days in the standard treatment group (p-value 0.008).
Most notably, out of a total of 100 clinical trials, 4 deaths occurred due to disease progression in the standard treatment group, while no death occurred in the Napabeltan-treated group.
Based on the results of phase 2 clinical trials in Russia, Chong Kun Dang plans to apply for approval of phase 3 clinical trials to the Ministry of Food and Drug Safety within this month and conditional approval as a treatment for COVID-19 for severely high-risk patients. In phase 3 clinical trials, the effectiveness and safety of Napabeltan will be demonstrated through large domestic and foreign patient groups.
An official from Chong Kun Dang said, “We expect Napaveltan to be an important alternative in the absence of COVID-19 treatment for severely high-risk patients.” “We will demonstrate the excellent therapeutic efficacy of Paveltan and will also push forward applications for emergency use approval overseas.” Online News Team firstname.lastname@example.org
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