The Food and Drug Administration (FDA) has granted Fast Track designation to PLG0206 for the treatment of periprosthetic joint infection (PJI).
PLG0206 is an investigational, broad-spectrum, anti-biofilm, anti-infective peptide therapeutic. It is designed to selectively target persistent bacterial pathogens within the biofilm that evade standard-of-care antibiotics by disrupting bacterial membranes, leading to bacterial cell death.
In preclinical studies, PLG0206 was found to have rapidly bactericidal, broad-spectrum activity against a variety of pathogens. The product is currently being evaluated in a phase 1b study (ClinicalTrials.gov Identifier: NCT05137314) in patients undergoing debridement, antibiotics, and implant retention (DAIR) surgery for the treatment of PJI occurring after total knee arthroplasty.
“At any time following surgery, patients can develop PJI, a devastating and life-threatening condition with suboptimal treatment options and a high mortality rate,” said David Huang, MD, PhD, Chief Medical Officer of Peptilogics. “Receiving the FDA’s Fast Track designation supports our efforts to improve the standard of care for those impacted by PJI.”
The FDA previously granted Orphan Drug and Qualified Infectious Disease Product (QIDP) designations to PLG0206 for this indication.
Peptilogics receives FDA Fast Track designation for PLG0206, an investigational peptide therapeutic in development for the treatment of periprosthetic joint infection. News release. Peptilogics. Accessed July 19, 2022. https://www.businesswire.com/news/home/20220719005313/en/Peptilogics-Receives-FDA-Fast-Track-Designation-for-PLG0206-an-Investigational-Peptide-Therapeutic-in-Development-for-the-Treatment-of-Periprosthetic-Joint-Infection