US FDA grants fast track designation to Aridis’ AR-301 product candidate

The product is currently in Phase 2a clinical trial to treat hospital-acquired and ventilator-associated pneumonia (HAP and VAP) caused by Staphylococcus aureus, including multi-drug resistant MRSA strains.

Aridis is undertaking the randomized, double-blind, placebo-controlled study in 52 patients comparing the safety and efficacy of AR-301 as adjunctive therapy with standard-of-care antibiotics versus antibiotics alone.

The European Union has granted orphan drug designation to AR-301, which has already showed bettyer prophylactic and therapeutic efficacy in mouse models of S. aureus pneumonia.

Aridis Pharmaceuticals founder and CEO Vu Truong said: "This is our second product candidate to receive FDA Fast Track designation this year, which provides an accelerated development and regulatory review pathway.

"Together with Aerucin™, our broadly active human IgG1 mAb against P. aeruginosa, these innovative mAbs provide a significant opportunity to improve patient outcomes from potentially life-threatening infections caused by two of the most common and difficult to treat pathogens."

Aridis recently expanded its ongoing Phase 2 trial of AR-301 into the US. Patient enrollment is expected to be completed in the first half of next year.