Aridis Pharmaceuticals, Inc. has announced 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.”
Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. Companies that receive Fast Track designation are allowed to submit New Drug Applications (NDA) or Biologics License Applications (BLA) on a rolling basis, expediting the FDA review process, and benefiting from more frequent communication with the FDA to discuss all aspects of clinical development. Additionally, drugs that receive Fast Track designation are eligible for accelerated approval and priority review.