Aridis Pharmaceuticals Gets FDA Product Designation for AR-301

By Chris Wack

Aridis Pharmaceuticals said Wednesday that the U.S. Food and Drug Administration has granted Qualified Infectious Disease Product Designation for AR-301, a fully human IgG1 monoclonal antibody in Phase 3 clinical development as an adjunctive therapy for pneumonia caused by gram-positive Staphylococcus aureus.

The company received positive feedback from the FDA in May on its 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, the FDA agreed to the proposed expansion of the confirmatory Phase 3 study in S. aureus VAP patients to include ventilated hospital-acquired pneumonia and ventilated community-acquired pneumonia patients.

The company said an estimated 1 million patients annually are affected by ventilator associated pneumonia, which occurs in hospitalized patients receiving respiratory support.

Aridis shares were up 64% to 44 cents in premarket trading.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

07-12-23 0835ET