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Aridis Receives FDA Fast Track Designation

Aerucin developed for treating hospital acquired and ventilator associated pneumonia

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to biopharma company Aridis Pharmaceuticals’ 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.

“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,” said Vu Truong, founder and chief executive officer, Aridis. “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.”

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