MFDS Rejects Komipharm COVID-19 Treatment 'Panapix' Emergency Clinical Trial Plan

[Asia Economy Reporter Minji Lee] Komipharm announced on the 8th that the Ministry of Food and Drug Safety rejected the Phase 2/3 clinical trial plan for the PAX-1 regimen orally administered to COVID-19 patients.

The company stated, "The review concluded that this is an immunomodulator, not an antiviral drug, and its effects may vary depending on the type and condition of the disease," adding, "It is necessary to submit efficacy test data that can demonstrate anti-inflammatory effects in viral infection animal models and clinical efficacy."

In response, the company said, "We will promptly confirm the specific reasons for the rejection and establish a response plan to reapply."

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