PITTSBURGH--(BUSINESS WIRE)--Peptilogics, a biotech company engineering peptide therapeutics to improve the treatment landscape for patients with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s lead drug candidate, PLG0206, for the treatment of periprosthetic joint infection (PJI).
“Total joint replacements are the most common major surgical procedure performed annually across the globe. 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, M.D., Ph.D., 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. We look forward to continuing to evaluate PLG0206’s potential to address the unique challenges of the disease and help patients in need.”
Fast Track designation is granted by the FDA to expedite the development and review of new treatments for serious or life-threatening diseases with high unmet medical need. The FDA has previously granted PLG0206 Orphan Drug Designation and Qualified Infectious Disease Product status for the treatment of PJI. According to Marc Lesnick, Ph.D., SVP of Regulatory Affairs, “these designations are indicative both of the serious nature of the disease, as well as the transformative potential of our treatment.”
Peptilogics is currently evaluating the safety and efficacy of PLG0206 in a Phase 1b open-label, dose-escalating study in patients undergoing debridement, antibiotics, and implant retention (DAIR) surgery for the treatment of PJI occurring after total knee arthroplasty (TKA). For additional information about the trial, please visit www.clinicaltrials.gov using the study identifier NCT05137314.
Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is sponsored by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The content is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.
PLG0206 is an investigational, broad-spectrum, anti-biofilm, anti-infective peptide therapeutic currently in clinical development for the treatment of PJI. PLG0206 was designed with a unique mechanism of action that allows it to directly address persistent bacterial pathogens within the biofilm that evade standard-of-care antibiotics by targeting and disrupting bacterial membranes to trigger bacterial cell death. In both in vitro and non-clinical studies, PLG0206 has demonstrated best-in-class, rapidly bactericidal, broad-spectrum activity against a variety of pathogens including those identified by the World Health Organization and the Centers for Disease Control and Prevention as critical, urgent or high-priority targets, regardless of resistance phenotype. PLG0206 has been granted FDA Orphan Drug Designation for the treatment of PJI and has also been designated as a Qualified Infectious Disease Product (QIDP).
About Periprosthetic Joint Infection (PJI)
More than one million total joint replacements are performed annually in the U.S., a number that is expected to grow to four million annual procedures by 2030 due to an aging and active population. Following joint replacement, approximately 2% of patients will develop 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. The current standard of care has up to a 60% four-year failure rate and results in a substantial number of patient deaths, evidenced by a 25% five-year mortality rate.
Peptilogics engineers peptide therapeutics to radically improve the treatment landscape for patients with life-threatening diseases. Through biological and pharmaceutical expertise, novel artificial intelligence algorithms and purpose-built super-computing, Peptilogics is advancing an extensive therapeutic pipeline and accelerating discovery efforts at a pace and scale that was previously impossible. Peptilogics is backed by visionary investors in life science and technology including Peter Thiel, Presight Capital, Founders Fund, CARB-X and Cystic Fibrosis Foundation. For more information about Peptilogics, visit www.peptilogics.com or follow the company on Twitter and LinkedIn.