Chong Kun Dang's 'Napabeltan' Applies for Conditional Approval as COVID-19 Treatment

Phase 2 Clinical Trial in 104 Severe High-Risk Patients Shows 'p-value 0.012'
Supply Negotiations Underway with UK, France, and Others... Large-Scale Phase 3 Trial Planned

[Asia Economy Reporter Kim Ji-hee] Chong Kun Dang has applied to the Ministry of Food and Drug Safety on the 8th for conditional approval and Phase 3 clinical trial authorization of ‘Napabeltan’ (active ingredient Nafamostat), a COVID-19 treatment for severely high-risk patients.

Last year, Chong Kun Dang conducted a Phase 2 clinical trial in Russia involving 104 severe COVID-19 patients, demonstrating that Napabeltan prevents symptom worsening in severely high-risk COVID-19 patients and improves treatment duration and success rates. Notably, the treatment mechanism is effective against variants, raising expectations that it can respond to the spread of various variant viruses.

In the Phase 2 trial, 104 severely high-risk patients were randomly assigned to the Napabeltan group or the standard treatment group and administered the drug for 10 days. Analyzing results from 36 high-risk patients with an early warning score (NEWS) of 7 or higher, the p-value, a statistical significance indicator, was 0.012, clearly meeting the target threshold of below 0.05.

In the Napabeltan group, 61.1% of patients reached recovery immediately after the 10-day administration, showing superior effects compared to 11.1% in the standard treatment group. After the full 28-day clinical period, 94.4% of the Napabeltan group and 61.1% of the standard treatment group recovered. Notably, there were 4 deaths due to COVID-19 symptom worsening in the standard treatment group, whereas no deaths occurred in the Napabeltan group.

Chong Kun Dang stated, "Based on the Phase 2 clinical results demonstrating COVID-19 treatment efficacy, we are in supply negotiations for Napabeltan with several countries including the UK, France, Japan, and Russia," adding, "This approval application aims to secure clear evidence necessary for overseas emergency use authorization, enabling rapid export of domestically produced COVID-19 treatments."

Along with the conditional approval application, Chong Kun Dang also submitted a large-scale Phase 3 clinical trial protocol. The Phase 3 trial will involve approximately 600 severely high-risk patients and will be conducted at over 10 institutions in Korea, including Seoul National University Hospital. To expedite patient recruitment, global clinical trials will also be pursued.

A Chong Kun Dang official said, “Napabeltan is the only drug that has definitively proven treatment efficacy for severely high-risk COVID-19 patients in the absence of existing treatments,” adding, “It is especially applicable to various variant viruses and will significantly contribute to preventing COVID-19 resurgence caused by variants.”

The Ministry of Food and Drug Safety stated, "We plan to thoroughly review the submitted non-clinical and clinical data, consult external experts, and rigorously verify the submitted materials to decide on the approval change."

This content was produced with the assistance of AI translation services.