Chong Kun Dang applied for COVID-19 treatment

The effect of improving symptoms and shortening the recovery period was confirmed in patients with severe high-risk groups

Discussions on exports with a number of foreign countries such as the UK, France, and Russia are in progress

Simultaneous application for phase 3 clinical trial plan for 600 severely ill patients

Nafabelltan

Chong Kun Dang announced on the 8th that it has applied to the MFDS for approval of the conditional marketing authorization (CMA) and phase 3 clinical trial plan of Nafabelltan (Nafamostat) as a treatment for COVID-19 for patients with severe and high risk.

 

Nafabelltan is a drug used as a therapeutic agent for acute pancreatitis and as an anticoagulant.

 

Nafabelltan inhibits the proteolytic enzyme TMPRSS2, which is known to be involved in the cell penetration process of COVID-19.

 

Chong Kun Dang confirmed the possibility of developing it as a COVID-19 treatment in a drug re-creation study by Institut Pasteur Korea, and has been promoting the development of COVID-19 treatment with Institut Pasteur Korea and Korea Institute of Radiological Medical Sciences since last June.

 

Through phase 2 clinical trials conducted on 104 severely ill patients with COVID-19 in Russia last year, it has secured the results of preventing worsening of symptoms and significantly improving the treatment period and treatment rate.

 

According to Chong Kun Dang, 104 severely high-risk patients were randomly assigned to Nafabelltan-treated group or standard treatment group, administered drugs for 10 days, and analyzed the results of 36 high-risk groups with a National Early Warning Score (NEWS) of 7 or more.

 

The P value was 0.012.

 

It is explained that statistical significance was secured as the P value, which is the verification target, was confirmed to be less than 0.05.

 

The Nafabelltan group showed superior effects compared to 11.1% of the standard treatment group, with 61.1% reaching a recovery state immediately after 10 days of drug administration.

 

After 28 days, the total clinical period, the recovery rate of the Nafabelltan group was 94.4% and that of the standard treatment group was 61.1%, showing a statistically significant difference.

 

4 cases of death due to worsening symptoms of COVID-19 occurred in the standard treatment group, but not one in the Nafabelltan group, suggesting the possibility of preventing the death of high-risk patients.

 

Based on the results of this phase 2 clinical trial, Chong Kun Dang is conducting consultations on supply of Nafabelltan with a number of countries including the UK, France, Japan, and Russia.

 

Through this application for approval from the MFDS, it is planning to promote the rapid export of domestic COVID-19 treatments while securing a clear basis for approval for overseas emergency use.

 

The MFDS also announced its intention to thoroughly verify the submitted non-clinical and clinical data through consultation with external experts.

 

Chong Kun Dang is speeding up commercialization by submitting a large-scale phase 3 clinical trial plan along with the conditional marketing authorisation.

 

It targets about 600 severely high-risk patients and are conducted in more than 10 institutions including Seoul National University Hospital in Korea.

 

Global clinical trials are also planned for rapid patient recruitment.

 

An official from Chong Kun Dang said, "Nafabelltan is the only drug that has reliably proved its therapeutic effect in the absence of COVID-19 treatment for severely high-risk patients.

 

It can be applied to various mutant viruses, so it is expected that it will greatly contribute to preventing the re-proliferation of COVID-19 caused by mutations." Chong Kun Dang is participating in the clinical trials of ASCOT, a global clinical trial project in Australia, New Zealand and India.

 

Phase 2 clinical trials are also in progress in Mexico and Senegal.

 

The MFDS initiated a review of the approval of Nafabelltan.

 

An official from the MFDS said, "We plan to carefully review the submitted non-clinical and clinical data, and plan to thoroughly verify the submitted data through external expert advice and decide whether to approve the change."