South Korea’s cancer and diabetes drug developer Aptabio has obtained approval for a Phase 2 trial of its oral coronavirus cure APX-115 from that the US Food and Drug Administration (FDA), the company announced on Thursday.
APX-115 – a transmembrane enzyme NADPH oxidase (NOX) inhibitor – has already been studied in Europe for the treatment of the patients with diabetes complications.
Aptabio plans to initiate the study in 80 Covid-19 patients at 12 medical centers across the U.S. following the FDA approval. The study will be conducted by COVANCE, a clinical research organization.
A possible common pathogenic mechanism of hypertension, diabetes, cardiovascular comorbidities associated with Covid-19 is the activation of the reactive oxygen species (ROS) generating NOXs, according to a study published in Frontiers in Cellular and Infection Microbiology. Endosomal NOX activation is essential for Covid-19 infection and Aptabio`s APX-115 inhibits NOX2 and ROS in the endosome, blocking the virus pathway, according to the company.
The Phase 2 study protocol was submitted to the FDA in December last year. Aptabio said the latest approval came quickly thanks to data from a Phase 1 trial in Europe, where there were no safety signals.
The company said it will complete a confirmatory clinical trial based upon positive results of the Phase 2 trial and file for emergency use authorization.
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