ARIDIS PHARMACEUTICALS, INC. Aridis Pharmaceuticals, Inc. 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. 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. Aridis' Pipeline: AR-301 (VAP/HAP/CAP). AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in ventilator associated pneumonia (VAP), ventilated hospital acquired pneumonia (HAP), and ventilated community acquired pneumonia (CAP) patients. AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients.
This program is currently in a Phase 2a clinical study in CF patients. AR-320 (VAP). AR-320 is a fully human mAb targeting S. aureus alpha-toxin for prevention of VAP.
Statistically significant Phase 2 data in the target population of those = 65 years of age was published in the September 2021 Lancet Infectious Diseases journal. The Company has completed discussions with the EMA and FDA on study design and recently launched the Phase 3 study. AR-701 (COVID-19).
AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that target multiple sites on the spike proteins of the SARS-CoV-2 virus. AR-101 (HAP). AR-101 is a fully human IgM mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa HAP cases worldwide. This program is licensed to the Serum Institute of India and Shenzhen Arimab.
AR-201Â (RSV infection). AR-201 is a fully human IgG1 mAb directed against the F-protein of diverse clinical isolates of respiratory syncytial virus (RSV). This program is licensed exclusively to the Serum Institute of India.
AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.
