Treatment for Prosthetic Joint Infections Gets FDA’s QIDP Designation

PJI is a challenging complication of joint arthroplasty with few effective treatment options.

Peptilogics announced that the Food and Drug Administration (FDA) has designated Qualified Infectious Disease Product (QIDP) to PLG0206 for the treatment of prosthetic joint infections (PJI), a serious complication of joint arthroplasty. 

PLG0206 is designed with the Company’s eCAP (engineered cationic antibiotic peptide) platform that enhances the antimicrobial activity found in naturally occurring peptides and improves the safety profile. eCAPs are being engineered as intravenous (IV) antibiotics with highly amplified activity by targeting and disrupting bacterial membranes. This causes rapid bacterial eradication via chemical imbalance without inducing lysis. Unlike most of the currently approved antibiotics that are effective against actively growing bacteria, eCAPs have shown activity against growing and dormant bacteria. 

Preclinical studies showed that treatment with PLG0206 eradicated different biofilm-associated bacteria (including methicillin-sensitive  [MSSA] and methicillin-resistant [MRSA] Staphylococcus aureus isolates), sterilizing implants after short exposure in a biofilm model. The data suggested PLG0206 could quickly kill implant-associated biofilm bacteria in a clinical setting. 

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“PLG0206’s potency against the spectrum of multidrug-resistant pathogens commonly found in prosthetic joint infections differentiates this investigational compound from antibiotic approaches currently used in clinical practice,” said Ian Friedland, MD, a clinical and regulatory advisor to Peptilogics.

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