Chong Kun Dang¡¯s Covid-19 cure shows positive results in Phase 2 trial

Chong Kun Dang (CKD) reported positive interim results from the clinical trials of its investigational Covid-19 therapy Napabeltan (nafamostat mesylate), raising hope for the availability of one more Korean Covid-19 treatment option following Celltrion¡¯s Rekirona.

The Korean pharmaceutical company announced on Thursday that Napabeltan showed about 2.9 times higher treatment effectiveness in patients with high-risk groups than those treated with a standard therapy.

CKD revealed the results of a Phase 2 trial involving more than 100 Covid-19 patients in Russia, where statistical significance set at p < 0.05 was met with 0.012.

In the latest trial approved by the Russian Ministry of Health in August last year, some 100 patients were randomized to receive either Napabeltan or standard of care antiviral therapy plus oxygen treatment for 10 days.

Data showed statistically significant symptom improvement and recovery in 36 high-risk patients with a national early warning score (NEWS) of more than 7 points after treatment with Napabeltan over standard of care. Symptom improvement was observed in 61.1 percent of high-risk patients after treatment with Napabeltan compared to 11.1 percent in the standard treatment arm.

The NEWS is an index used to predict the fatality of pneumonia following coronavirus infection, and patients are known to be 18 times more likely to die compared to the general population when their NEWS exceeds 7 points.

Symptom improvement was also time dependent. During the follow-up period of 28 days, the rate of symptom improvement among the severely ill patients who took Napabeltan reached 94.4 percent, whereas the figure in the standard treatment arm was 61.1 percent. The median time to recovery was 10 days in the Napabeltan treatment group vs 14 days in the standard treatment group. No mortality was reported in the Napabeltan treatment group, but there were four deaths in the standard treatment group due to worsening symptoms, according to the company.

Based on the trial results, CKD will apply to Korea¡¯s Ministry of Food and Drug Safety for approval of Phase 3 clinical trials and conditional authorization of Napabeltan as a Covid-19 cure for high-risk patients within this month.

If approved, Napabeltan would become the second Korean coronavirus cure following Celltrion¡¯s neutralizing antibody therapy Rekirona (regdanvimab), meaning the availability of both treatment options to treat a broader range of patients with mild, moderate and severe symptoms.

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