MFDS Advisory Panel: "Chong Kun Dang COVID-19 Treatment Fails to Prove Effectiveness... Additional Clinical Trials Needed" (Comprehensive)

[Asia Economy Reporter Seo So-jeong] An expert advisory panel has concluded that Chong Kun Dang's COVID-19 treatment drug 'Napabeltan Injection' (active ingredient Nafamostat Mesylate) failed to demonstrate therapeutic efficacy.

On the 17th, the Ministry of Food and Drug Safety held a meeting of the COVID-19 treatment and vaccine safety and efficacy verification advisory panel and discussed whether it was appropriate to recognize the therapeutic effect of Napabeltan based on the results of the phase 2 clinical trial. The panel announced that efficacy was not proven.

The submitted clinical trial data consisted of one phase 2 clinical trial conducted in Russia, where 104 patients at 13 clinical trial institutions in Russia were randomly assigned to a control group receiving standard COVID-19 treatment and a test group receiving both standard treatment and the investigational drug.

Napabeltan was administered to the test group for 10 days during the clinical trial, and when comparing and evaluating the time taken for clinical improvement between the test and control groups, both groups showed 11 days with no difference, failing to prove efficacy.

Additionally, the time for virus test results to convert from positive to negative was also 4 days in both the test and control groups, showing no difference.

The verification advisory panel stated that the submitted phase 2 clinical trial results alone were insufficient to recognize the therapeutic effect of this drug and suggested that additional clinical trials confirming therapeutic efficacy are necessary.

The Ministry of Food and Drug Safety said, "According to the results of the verification advisory panel meeting, the next step in the triple advisory process for COVID-19 treatments and vaccines, the Central Pharmaceutical Affairs Deliberation Committee meeting, will not be held," adding, "We plan to support the faithful design and progress of the phase 3 clinical trial plan for Napabeltan in the future."

In response, a Chong Kun Dang official stated, "Statistical significance was observed in some specific patient groups with early warning scores of 7 or higher, such as respiratory rate, oxygen saturation, and supplemental oxygen," and added, "We will strive to supplement and proceed with the phase 3 clinical trial plan."

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