Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to its fully human monoclonal antibody Aerucin™ for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa. Aridis completed enrollment and dosing in a Phase 1 clinical study of Aerucin. Results are expected in the fourth quarter of this year.
Vu Truong, Ph.D., Founder and CEO of Aridis, stated, "We are pleased to receive Fast Track designation for Aerucin as it provides an accelerated development and regulatory review pathway, and if approved, may lead to expedited availability of Aerucin to critically ill patients with hospital-acquired and ventilator-associated pneumonia. This is an encouraging milestone for Aridis and is in line with our strategy to obtain Fast-Track, Orphan Drug, Qualified Infectious Diseases Product (QIDP), and Breakthrough Therapy designations for some or all of our product candidates."
Aridis Pharmaceuticals, Inc.