Aridis Pharmaceuticals’ AR-301 receives FDA’s QIDP designation

Aridis Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has granted Qualified Infectious Disease Product, QIDP, Designation under the Generating Antibiotic Incentives Now, GAIN, Act for AR-301, a fully human IgG1 monoclonal antibody currently in Phase 3 clinical development as an adjunctive therapy for pneumonia caused by gram-positive Staphylococcus aureus in critically ill hospitalized patients. “To our knowledge, AR-301 is the very first antibacterial biologics 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,” stated Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. “Our AR-301 program 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. This sought-after designation positions our AR-301 program extremely well as we continue to advance it through a confirmatory Phase 3 trial and license application.”