PITTSBURGH--(BUSINESS WIRE)--Peptilogics, a clinical stage biotechnology company, has completed the enrollment of a Phase 1b trial for PLG0206 in patients undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for treatment of a Periprosthetic Joint Infection (PJI) occurring after Total Knee Arthroplasty (TKA). The trial is an open-label dose-escalating study with two dose cohorts of seven patients each compared to historical controls.
Peptilogics will present the interim top-line data on PLG0206 from their ongoing Phase 1b trial at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). The presentation will cover clinical safety and tolerability data, alongside reinfection rates for the low dose (3 mg/mL) cohort at the 3-month follow-up highlighting the potent antimicrobial properties of Peptilogics’ engineered peptide PLG0206 for the treatment of periprosthetic joint infection (PJI), a life-threatening complication that patients may develop following joint replacement surgery. In-depth analysis from the low dose cohort along with the readout from the high-dose cohort will be presented at an upcoming conference.
“PJI is the last remaining problem in what is otherwise becoming a standard surgery all over the world. More than seven million total joint replacements will be performed annually in the seven major markets by 2030, which will require over 300,000 surgeries per year to try and resolve the infections,” said Jonathan Steckbeck, Chief Executive Officer of Peptilogics. “PJI is an enormous clinical and economic burden on the healthcare system due to the poor outcomes associated with the current standard of care, which includes multiple major surgeries and hospitalizations followed by high doses of antibiotics. We are working to develop a broad-spectrum curative solution that can address all the challenges of bacterial biofilm in infected joints.”
“Patients with PJI are a population with significant unmet medical need, as the current standard of care falls short of addressing these infections,” said David Huang, Chief Medical Officer at Peptilogics. “With enrollment complete for our Phase 1b study, we look forward to continuing the clinical development of PLG0206 for this important patient population.”
The presentation details at ECCMID are:
Title: Interim data readout of PLG0206 from Ph1b trial
Time of presentation: Saturday, April 15 at 12:15 – 1:15 PM (Western European Summer Time Zone)
Session: Therapeutic Pipeline Corner
Presenter: Atul Deshpande, Chief Strategy Officer
Overview: Top line interim data for safety and tolerability from ongoing Ph1b clinical trial.
Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by an award from Wellcome (WT224842). The content of this press release 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 seven million total joint replacements will be performed annually in the major markets (US, UK, EU, JP) by 2030. Following joint replacement, over 150,000 patients will develop a PJI, a serious life-threatening condition, which often necessitates continuous antibiotic usage, multiple high-risk surgical procedures, and implant removal requiring more than 300,000 surgeries 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 therapeutic candidates 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.