Case Study

Peptilogics Receives Qualified Infectious Disease Product Designation from FDA for Lead Compound PLG0206 as a Treatment for Prosthetic Joint Infection

Company Peptilogics Inc., United States
Sub category of Industry Biotechs
Category of commitment Research & Science
Which product(s) Alternative technologies
Key focus Collaboration, Early-stage R&D, Incentives, Innovation, Manufacturing, Research & Science
Key partners of the program Academia & think tanks
Geographic focus Global

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.

Ian Friedland, M.D., clinical and regulatory advisor to Peptilogics

Health needs

Prosthetic Joint Infection (PJI) is one of the most challenging complications of joint arthroplasty and a serious, life threatening condition with few effective treatment options.

“Total joint replacement is one of the most common surgical procedures in the United States, and joint infection remains the most serious and costly reason for total knee arthroplasty failure,” said Kenneth Urish, M.D., Ph.D., Orthopedic Surgeon at the University of Pittsburgh and senior author of the Nature Scientific Reports publication. “The current first line treatment options for PJI are far from being universally effective, frequently require removal and revision of the prosthesis, and are associated with high rates of morbidity and mortality.”

Initiative’s objective

“Researchers estimate that by 2020, more than 65,000 patients per year with prosthetic joint implants will develop PJIs, resulting in over $1.6 billion in annual inpatient costs,” said Sanjay Kakkar M.D., chief executive officer of Peptilogics. “We are delighted that FDA has granted PLG0206 QIDP designation, and we look forward to advancing the compound into clinical development later this year.”

The Qualified Infectious Disease Product (QIDP) designation was created by the Generating Antibiotic Incentives Now (GAIN) Act, which was part of the FDA Safety and Innovation Act of 2012 (FDASIA). QIDP designation provides certain incentives for the development of new antibiotics, including an additional five years of market exclusivity, as well as eligibility for Priority Review and Fast Track designation.

Initiative’s description

PLG0206 was developed utilizing Peptilogics’ novel eCAP (engineered cationic antibiotic peptide) platform. This technology dramatically amplifies the antimicrobial activity found in naturally occurring peptides while at the same time potentially delivering an improved systemic safety profile. In preclinical studies published in Nature Scientific Reports in December 2017, PLG0206 eliminated a variety of biofilm-associated bacteria, including methicillin-sensitive (MSSA) and methicillin-resistant (MRSA) Staphylococcus aureus clinical isolates, sterilizing implants following short exposure in a biofilm model, suggesting that it could rapidly kill implant-associated biofilm bacteria in a clinical setting. “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, M.D., a clinical and regulatory advisor to Peptilogics and formerly the chief medical officer of Achaogen and VP clinical development at Cubist Pharmaceuticals.

Impact

Previously in September 2017, Peptilogics announced a $5.5 million Series A financing with major backing from Peter Thiel, and Sanjay Kakkar appointed as CEO. Later this year, Peptilogics is taking to clinical trials its lead compound PLG0206 that has the potential to change how PJI is treated, and to lessen the burden it poses in joint arthroplasty surgery.

Additional Information

The progress builds on eCAP, Peptilogics innovative peptide-based platform previously reported here

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