WVU Medicine physician enrolls their first patient in global periprosthetic joint infection clinical trial

WVU Medicine physicians are participating in their second Peptilogics study to treat peri-prosthetic joint infections (PJI) of the knee, which is infection after joint replacement surgery. In 2022, WVU was the first site to dose a patient with a new antimicrobial medication in the Phase 1b clinical trial for the treatment of PJI.  WVU, led by Principal Investigator Dr. Matthew Dietz, is now collaborating on the follow up study, a global Phase 2/3 RETAIN trial, onto which the team has already enrolled its first patient.

The trial, sponsored by Peptilogics Inc, a clinical stage biotech company that engineers peptide therapeutic solutions for patients with life-threatening diseases, developed the drug, PLG0206. This investigational medication is being assessed in the clinical trial for the treatment of PJI occurring after a total knee arthroplasty, or knee replacement surgery.

The drug is designed to directly address bacterial pathogens within the biofilm that are difficult to treat with standard antibiotics. The drug has been granted Orphan Drug, Fast Track, and Qualified Infectious Disease Designations by the U.S. Food and Drug Administration for the treatment of PJI.

“We are excited to help advance the care of patients who have been diagnosed with prosthetic joint infection. The use of the engineered antimicrobial peptide allows us to hopefully retain knee replacements while effectively treating the patient’s infection. This is a big step in finding a solution that has plagued the orthopaedic community for years.” Matthew Dietz, MD, WVU Medicine orthopaedic surgeon and Principal Investigator for the study, said. “These infections have historically been difficult to treat. It is our hope that this new drug will provide a novel treatment modality.”

According to a study published by the National Institutes for Health, each year, close to three million total joint replacements are performed in the U.S., a number that is expected to significantly increase by 2030 due to an aging and active population. Following joint replacement, the most devastating complication a patient can face is contracting a PJI, a serious life-threatening condition, which often necessitates continuous antibiotic usage, multiple high-risk surgical procedures, and implant removal with limited ability to resolve the infection. Studies have shown that 35–55% of patients undergoing debridement, antibiotics, and implant retention for PJI of the knee, one of the current standards of care, experience treatment failure. Given the high unmet need, it is the hope that this new treatment will reduce those rates.

“We are thrilled to have WVU, Dr. Dietz, and the entire study team partnering with us on the RETAIN trial,” said Jonathan Steckbeck, PhD, founder and CEO of Peptilogics. “PLG0206 has demonstrated potential best-in-class, rapidly bactericidal, broad-spectrum activity against a variety of biofilm pathogens in both in vitro and non-clinical studies, and safety in previously completed Phase 1 studies in both healthy volunteers and patients with PJI, with promising outcomes in PJI patients. This global trial provides an important opportunity to evaluate the efficacy of PLG0206 compared with standard of care alone, with the goal of significantly improving outcomes for patients suffering from this devastating infection.”