TFS Chemicals - Aspire
Pharma Focus America
Sino Biological - Cytokine

Aridis' AR-301 Monoclonal Antibody Earns FDA's Qualified Infectious Diseases Product (QIDP) Designation, Among the Early Biologics to Receive the Recognition

Thursday, July 13, 2023

Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on developing novel anti-infective therapies, has announced that its AR-301 monoclonal antibody has received the Qualified Infectious Disease Product (QIDP) Designation from the U.S. Food and Drug Administration (FDA). This designation, granted under the Generating Antibiotic Incentives Now (GAIN) Act, recognizes AR-301 as one of the first antibacterial biologics to receive this status.

AR-301 is a fully human IgG1 monoclonal antibody currently in Phase 3 clinical development. It is being studied as an adjunctive therapy for pneumonia caused by gram-positive Staphylococcus aureus in critically ill hospitalized patients.

The QIDP designation provides several benefits to the AR-301 program, including priority review and expedited drug development and regulatory review processes. This designation complements the Fast-Track status previously granted to AR-301.

Vu Truong, Ph.D., the CEO of Aridis Pharmaceuticals, expressed the significance of this milestone not only for the company but also for the broader biologic solutions in combating antimicrobial resistance. The QIDP designation will facilitate the advancement of AR-301 through a confirmatory Phase 3 trial and the subsequent license application.

The QIDP designation was established as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Generating Antibiotic Incentives Now (GAIN) Act in 2012. It aims to encourage the development of treatments for antibiotic-resistant infections that pose serious or life-threatening risks. The recent expansion of QIDP eligibility to include biological products further strengthens its impact.

Aridis Pharmaceuticals has received positive feedback from the FDA regarding its proposed Phase 3 study of AR-301. The study will support the submission of a Biologics License Application (BLA). Additionally, the FDA has approved the expansion of the confirmatory Phase 3 trial to include patients with ventilator-associated pneumonia (VAP), hospital-acquired pneumonia (HAP), and community-acquired pneumonia (CAP) caused by Staphylococcus aureus.

patheon - Mastering API production at every scaleWorld Vaccine Congress Europe 2024World Orphan Drug Congress 2024Future Labs Live USA 2024patheon - Revolutionizing PharmaHealthcare CNO SummitHealthcare CMO Summit