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.”
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