Komipharm Voluntarily Withdraws COVID-19 Treatment Clinical Trial Application in Italy
[Asia Economy Reporter Geum Bo-ryeong] Komipharm announced on the 8th that it has voluntarily withdrawn its application for the Phase 2/3 clinical trial plan to the Italian Medicines Agency (AIFA) for evaluating the safety and efficacy of PAX-1 in pneumonia patients caused by the novel coronavirus infection (COVID-19).
Komipharm explained, "AIFA provided feedback that the submitted data pertain to a clinical trial as an immunomodulator rather than an antiviral agent, which could interfere with patient recruitment for other ongoing studies in Italy. Considering the difficulties in patient selection and the negative opinion, we decided to withdraw the clinical trial plan application."
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Regarding future plans, Komipharm stated, "This clinical trial plan application is a multinational, multicenter trial. We completed the application for the Phase 2/3 clinical trial in Spain on July 10 and received a favorable review opinion from the central ethics committee. We plan to apply for additional clinical trials in European countries with a high number of COVID-19 patients."
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