AMR Industry Alliance Publishes Case Study Regarding Peptilogics QIDP Designation
The AMR Industry Alliance features case studies to provide snap-shots from across the life-sciences industry, share information on the tangible steps taken to invest in new research to develop new antibiotics and vaccines, prevent infection ,and improve appropriate use of antibiotics.
Additional details can be found here.
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.”
“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.
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.
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.
The progress builds on eCAP, Peptilogics innovative peptide-based platform previously reported by AMR Alliance.
About the AMR Industry Alliance
The AMR Industry Alliance is a coalition of over 100 biotechnology, diagnostic, generics and research-based biopharmaceutical companies and trade associations that was formed to drive and measure industry progress to curb antimicrobial resistance. The AMR Industry Alliance ensures that signatories collectively deliver on the specific commitments made in the Industry Declaration on AMR and the Roadmap and measures progress made in the fight against antimicrobial resistance.