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news.US-based Aridis Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for its fully human monoclonal antibody Aerucin to treat hospital-acquired and ventilator-associated pneumonia caused by pseudomonas aeruginosa.
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The company has completed enrollment and dosing in a Phase I clinical trial of Aerucin and the results are expected to be reported in the fourth quarter of this year.
Aerucin is a fully human immunoglobulin G (IgG) mAb targeting P. aeruginosa bacteria that exhibits broad binding to greater than 90% of clinical isolates of P. aeruginosa.
Initially, the product candidate was developed as an adjunctive anti-infective to treat hospital-acquired and ventilator-associated pneumonia due to P. aeruginosa.
Aridis founder and CEO Vu Truong said: "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."
Currently, Aerucin is in a Phase I clinical trial evaluating safety and pharmacokinetics in healthy adults, which is expected to complete in the fourth quarter of this year.
The drug candidate has received funding support from the National Institutes of Health (NIH), during pre-clinical development through IND filing as well as clinical manufacturing of drug product for a planned Phase II trial.