It was confirmed that’Napabeltan’, developed by Chong Kun Dang as a treatment for severely ill patients with Corona 19, showed excellent effects in phase 2 clinical trials conducted in Russia. Based on these clinical results, Chong Kun Dang is planning to apply for conditional use to the Ministry of Food and Drug Safety during this month, so it is likely to become the second Corona 19 treatment in Korea after Celltrion’s antibody treatment’Rekirona,’ which applied for conditional approval at the end of last year. This has grown. In particular, if these products are approved by the Ministry of Food and Drug Safety, it is expected to provide an important turning point in responding to the Corona 19 incident, as it is possible to secure both domestically-made Corona 19 treatments for mild patients (Rekkirona) and severe patients (Napa Veltan).
On the 14th, Chong Kun Dang said, “As a result of evaluating various clinical indicators of phase 2 clinical trial conducted in Russia for 100 severely ill patients with Corona 19, we have secured statistical significance.” “The index to determine statistical significance, `p- If the value` value is less than 0.05, the effect of the new drug can be scientifically recognized, but the clinical result reached 0.012.”
Chong Kun Dang was approved by the Russian Ministry of Health in August of last year, and started clinical trials on September 25 of the same year. In the second phase of the clinical trial, Chong Kun Dang administered Napabeltan to half of the patients for 10 days for more than 100 confirmed patients with Corona 19, and the remaining patients received standard treatment with conventional antiviral drugs and oxygen therapy. As a result, it was explained that for 36 high-risk patients with an early warning score (NEWS) of 7 or more, Napabeltan showed excellent symptom improvement and recovery effects compared to the standard treatment group. The early warning score is an index that predicts the fatality of pneumonia following Corona 19 infection, and it is known that if it is 7 or more, the probability of death increases 18 times compared to the general public.
According to Chong Kun Dang, 61.1% of these high-risk patients showed improvement in symptoms for 10 days after taking napabeltan. On the other hand, the symptom improvement rate of the standard treatment group was only 11.1%, and the symptom improvement rate of the napabeltan group was 6 times higher. In particular, it is noteworthy that the longer the clinical progression period, the higher the rate of symptom improvement. The rate of symptomatic improvement among the severely ill patients who took napabeltan during the entire clinical period of 28 days reached 94.4%. During the same period, the symptom improvement rate of patients in the standard treatment group was 61.1%. The average time to recovery was 10 days for patients taking Napabeltan and 14 days for standard treatment group.
In this regard, Chong Kun Dang explained, “As a result of administering Napabeltan to patients with high risk of COVID-19, the overall treatment effect was 2.9 times higher than that of the standard treatment group.”
In addition, none of the napabeltan-treated patients died, but in the standard treatment group, four cases died as symptoms worsened. In response, Chong Kun Dang emphasized that “Napabeltan is the evidence that can suggest the possibility of napabeltan as a drug that prevents deaths from worsening symptoms in high-risk patients.” He said, “We expect Napa Beltan to be an important alternative in the absence of a COVID-19 treatment for severely high-risk patients,” he said. “We will also push for emergency use approval from overseas.”
Based on the results of phase 2 clinical trials in Russia, Chong Kun Dang is planning to apply for conditional approval and approval for phase 3 clinical trials as a COVID-19 treatment for high-risk patients with the Ministry of Food and Drug Safety this month.
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