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Primary outcome measures of safety and tolerability of AR-301 were achieved. AR-301 intravenous (IV) infusion was well tolerated. Adverse Events (AEs) and Serious Adverse Events (SAEs) reported over the 28-day study period for the single IV infusion were similar across the active and placebo treatment groups, with no SAEs deemed drug-related

Aridis Receives Agreement from the FDA on a Single Confirmatory Phase 3 Study of AR-301 and the ...

Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) today announced positive feedback from the FDA on the Company’s proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301, which is being developed as an adjunctive therapy in combination with standard of care (SOC) antibiotics for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus ( S. aureus ) in mechanically ventilated hospitalized patients

By Aridis Pharmaceuticals, Inc.
Published - May 31, 2023, 08:06 AM ET
Last Updated - May 06, 2024, 12:54 PM EDT

LOS GATOS, Calif., May 31, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) today announced positive feedback from the FDA on the Company’s proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301, which is being developed as an adjunctive therapy in combination with standard of care (SOC) antibiotics for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus ( S. aureus ) in mechanically ventilated hospitalized patients.

Key agreements with FDA:

  • FDA agreed on the design of the single confirmatory Phase 3 superiority study required to support the submission of a Biologics License Application (BLA).
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