Aptabio Applies for IND for Phase 2 Clinical Trial of COVID-19 Treatment to US FDA

[Asia Economy Reporter Park Jun-yi] Aptabio announced on the 31st that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical trial of its COVID-19 treatment candidate, ‘APX-115’.

Aptabio stated, "This Phase 2 clinical trial aims to verify the safety and efficacy of APX-115, and after analyzing the results, it can proceed to confirmatory clinical trials for therapeutic validation," adding, "Subsequently, expedited review procedures such as Emergency Use Authorization may be pursued."

However, the company added, "The statistical probability of the clinical trial drug receiving final approval as a pharmaceutical product is approximately 10%," and "there is a possibility that the clinical trial and approval process may yield results that do not meet expectations."