Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to AR-301, the Company's fully human anti-Staphylococcal alpha-toxin IgG1 monoclonal antibody (mAb). AR-301 is currently in Phase 2a clinical trial for the treatment of hospital-acquired and ventilator-associated pneumonia (HAP and VAP) caused by Staphylococcus aureus, including multi-drug resistant "MRSA" strains.
Vu Truong, Ph.D., Founder and CEO of Aridis, stated, "This is our second product candidate to receive FDA Fast Track designation this year, which provides an accelerated development and regulatory review pathway. Together with Aerucin™, our broadly active human IgG1 mAb against P. aeruginosa, these innovative mAbs provide a significant opportunity to improve patient outcomes from potentially life-threatening infections caused by two of the most common and difficult to treat pathogens. We recently expanded our ongoing Phase 2 trial of AR-301 into the U.S. and expect to complete patient enrollment in the first half of 2016, and in parallel, our Phase 1 trial of Aerucin™ remains on track for completion in the fourth quarter of this year. We look forward to achieving these significant milestones as we continue to execute our clinical development strategy."
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.
New pathway discovery explains MRSA's high-level antibiotic resistance