Aridis Pharmaceuticals has enrolled the first Covid-19 patient in a Phase III clinical trial assessing its monoclonal antibody, AR-301, to treat pneumonia caused by Staphylococcus aureus (S. aureus).
The Phase III trial is designed for patients who were on mechanical ventilation.
Covid-19 patients on long-term mechanical ventilation in the intensive care unit (ICU) are at risk of secondary infections or superinfections. A reported complication of Covid-19 superinfection is known to exacerbate morbidity and rate of mortality.
The ongoing Phase III trial of AR-301 enables the recruitment of participants with baseline characteristics inclusive of some Covid-19 patients.
AR-301 is not designed to treat Covid-19 infection but the drug candidate is expected to help address S. aureus-induced pneumonia.
Aridis Pharmaceuticals CEO Vu Truong said: “While AR-301 does not treat the virus that causes COVID-19 disease, it can potentially mitigate secondary S. aureus bacterial pneumonia, which represents a serious coronavirus complication and a cause of death in such patients.”
Launched in the first quarter of last year, the Phase III trial is set to enrol 240 patients at up to 160 clinical centres across 22 countries.
It is said to be the first Phase III superiority study of immunotherapy with a fully human monoclonal antibody for the treatment of acute S. aureus bacterial pneumonia in mechanically ventilated ICU patients.
The primary outcomes of the study are safety, tolerability, and clinical cure rates of standard of care (SoC) plus AR-301 compared to Soc alone.
The trial will also assess secondary measures, such as mortality, duration of intubation with ventilation, duration of ICU and hospital stay, and duration of antibiotic use.
Aridis expects the prospective, randomised, double blind, placebo controlled, parallel design study to be completed in August this year.