The company’s CEO, Vu Truong said “while AR-301 does not treat the virus that causes redacted disease, it can potentially mitigate secondary S. aureus bacterial pneumonia, which represents a serious redacted complication and a cause of death in such patients.”
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.
Even though the ongoing AR-301 Phase 3 study is not powered for statistical significance in the redacted patient population, the results from the redacted subpopulation could provide preliminary data on the impact of AR-301 on secondary S. aureus pneumonia complication in redacted patients. Aridis expects to report top line data in 1H-2021.
From the phase 2 results:
P-Value of 0.3962, which is
redacted 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 redacted 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 redacted patients.
https://www.clinicaltrials.gov/ct2/show/NCT03816956 (phase 3 – ongoing)
https://www.clinicaltrials.gov/ct2/show/results/NCT01589185 (phase 2 -completed)