The US Food and Drug Administration (FDA) granted Fast Track designation to Aridis Pharmaceuticals Inc's 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 chief executive officer 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.
Aerucin is a broadly reactive fully human immunoglobulin G (IgG), mAb targeting P. aeruginosa bacteria that exhibits broad binding to greater than 90 per cent of clinical isolates of P. aeruginosa. Aerucin is being developed initially as an adjunctive anti-infective to treat hospital-acquired and ventilator-associated pneumonia due to P. aeruginosa. Aerucin is currently in a phase 1 clinical trial evaluating safety and pharmacokinetics in healthy adults, which is expected to be complete in the fourth quarter of 2015. This product candidate has been supported extensively by funding 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 2 trial.
Pseudomonas infection is caused by strains of bacteria found widely in the environment. Pseudomonas aeruginosa (P. aeruginosa), is a Gram negative bacterium that causes a variety of infections in humans, and is particularly prevalent and lethal in pneumonia. Drugs targeting Gram- negative bacteria must cross both the inner and outer membranes of the bacterial cell, as compared to those directed against Gram-positive bacteria, which must only cross one cell membrane. As a result, Gram-negative bacteria tend to be more resistant to antibiotics and the body's own immune system. Serious infections usually occur in hospitalised patients and/or those with a compromised immune system. Patients in hospitals, especially those on ventilators, catheters, and with wounds form surgery are potentially at risk for serious, life-threatening infections. While typically treated with antibiotics, Pseudomonas infections are more difficult to treat in hospitals due to increased antibiotic resistance. According to the Center for Disease Control and Prevention (CDC), an estimated 51,000 healthcare-associated P. aeruginosa infections occur in the US each year.
Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX and pharmaceutical formulation technologies to produce novel infectious disease focused therapies.