Aridis Pharmaceuticals, Inc. (Nasdaq: NASDAQ: ARDS ), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today 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 (mAb) 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 (AMR)," 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."
Part of the Food and Drug Administration Safety and Innovation Act, FDASIA (June 2012), Title VIII – Generating Antibiotic Incentives Now (GAIN), the QIDP designation was created to encourage the development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. Recently, The Food and Drug Omnibus Reform Act of 2022 (FDORA), signed on 29-Dec-2022 as part of the Consolidated Appropriations Act, 2023, amends GAIN to expanded QIDP eligibility to include biological products.
An estimated one million patients annually are affected by ventilator associated pneumonia (VAP) that occurs in hospitalized patients receiving respiratory support, which is one of the most frequent ICU-acquired infections. AR-301 specifically targets S. aureus alpha-toxin, which has been implicated in the pathogenesis of pneumonia caused by S. aureus bacteria.
Aridis received positive feedback from the FDA in May 2023 on the Company's proposed single confirmatory Phase 3 study of AR-301. In addition to agreeing to the study required to support the submission of a Biologics License Application (BLA), the FDA agreed to the proposed expansion of the confirmatory Phase 3 study in S. aureus VAP patients to include ventilated hospital-acquired pneumonia (HAP) and ventilated community-acquired pneumonia (CAP) patients.
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