The US Food and Drug Administration (FDA) has granted a qualified infectious disease product (QIDP) designation to Aridis Pharmaceuticals’ IgG1 monoclonal antibody (mAb) AR-301.
AR-301 is in a Phase III trial evaluating its safety and efficacy as adjunctive therapy for ventilator-associated pneumonia.
Ventilator-associated pneumonia is one of the most common intensive care unit (ICU)-acquired infections in hospitalised patients receiving mechanical ventilatory support.
AR-301 (tosatoxumab) is a fully human IgG1 mAb that targets the S. aureus alpha-toxin. S. aureus is one of the bacteria that cause ventilator-associated pneumonia.
In a press release, Aridis CEO Vu Truong said: “To our knowledge, AR-301 is the very first antibacterial biologic to be awarded the QIDP designation, marking a significant milestone not only for Aridis but also for companies with biologic solutions to fighting antimicrobial resistance.
“Our AR-301 programme will now benefit from the FDA’s priority review, in addition to previously awarded fast-track status, allowing for accelerated drug development and regulatory review processes.”
In May 2023, Aridis received positive feedback from the FDA regarding the expansion of the randomised, placebo-controlled Phase III trial (NCT03816956) to include patients with ventilated hospital-acquired pneumonia and ventilated community-acquired pneumonia. The resulting study will support Aridis’ biologics license application with the FDA.
The tosatoxumab’s Phase III trial was initially delayed due to the Russia-Ukraine conflict, as enrolment was paused in the trial’s sites in the two countries.
As per GlobalData’s analysis, Aridis is expected to be an emerging player in the ventilator-associated pneumonia field with one late-stage and two mid-stage products currently in development, with forecasted sales of $188m in 2029 for tosatoxumab alone.
GlobalData is the parent company of Pharmaceutical Technology.