Aridis Pharmaceuticals, a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, announced the enrollment of its first COVID-19 patient in the company's ongoing phase 3 clinical trial of AR-301, a monoclonal antibody against S. aureus induced pneumonia in patients who were already on mechanical ventilators.
COVID-19 patients on prolonged mechanical ventilation in the intensive care unit (ICU) are prone to secondary infections (also called 'superinfections') by opportunistic pathogens such as bacteria. Superinfection is a reported complication in COVID-19 patients, which exacerbates morbidity and rate of mortality. The Company's ongoing AR-301 phase 3 study allows for the enrollment of patients with baseline characteristics which are inclusive of certain COVID-19 patients. "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," said Vu Truong, chief executive officer.
The AR-301 phase 3 clinical study was initiated in the first quarter of 2019 and is expected to enroll 240 patients at approximately 160 clinical centers in 22 countries. The trial represents the first ever phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute S. aureus bacterial pneumonia in mechanically ventilated ICU patients.
Respiratory viral infections such as influenza, SARS, and MERS are commonly associated with secondary infections by opportunistic pathogens such as bacteria and fungus. While there is currently limited data regarding superinfections/coinfections in COVID-19 pneumonia, morbidity and mortality in COVID-19 disease is thought in part due to secondary infections. Secondary infections occur in approximately 10% to 30% of cases in hospitalized, severely ill COVID-19 patients, with much greater frequency in the ICU setting. COVID-19 patients in the ICU are on mechanical ventilation for a median of 17 days, compared to 5-10 days without COVID-19 disease. Prolonged intubation time is associated with higher risk of hospital-acquired infection by multidrug-resistant bacterial pathogens. Even though the ongoing AR-301 phase 3 study is not powered for statistical significance in the COVID-19 patient population, the results from the COVID-19 subpopulation could provide preliminary data on the impact of AR-301 on secondary S. aureus pneumonia complication in COVID-19 patients.