Aridis Pharma Shares Double After FDA Clearance to Start AR-301 Pneumonia Study
By Chris Wack
Aridis Pharmaceuticals shares doubled in premarket trading to 37
cents a share on Wednesday after the company said it received
positive feedback from the Food and Drug Administration on its
proposed single confirmatory Phase 3 study of investigational
monoclonal antibody candidate AR-301.
The clinical-stage antibiotic add-on discovery company said it
is developing AR-301 as an adjunctive therapy in combination with
standard-of-care antibiotics for the treatment of pneumonia caused
by Gram-positive bacteria Staphylococcus aureus in mechanically
ventilated hospitalized patients.
Aridis said the FDA agreed on the design of a single
confirmatory Phase 3 superiority study required to support the
submission of a biologics license application for AR-301.
The FDA also agreed to a proposed expansion of the confirmatory
Phase 3 study of S. aureus ventilator-associated pneumonia patients
to include ventilated hospital-acquired pneumonia and ventilated
community-acquired pneumonia patients.
The Phase 3 study's primary efficacy endpoint would be a
clinical cure of pneumonia in adults 65 years old and over, at day
21 post-treatment. Its secondary endpoints would include clinical
cure rates of pneumonia in study subjects less than 65 years of
age, safety levels including all-cause mortality, and healthcare
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires
May 31, 2023 09:28 ET (13:28 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.