Peptilogics Receives Qualified Infectious Disease Product Designation from FDA for Lead Compound PLG
Builds on PLG0206 studies published in Nature Scientific Reports. Company to present at BIO in Boston on June 5.
Peptilogics, a development stage company utilizing its innovative peptide platform to treat multidrug-resistant bacterial infections, today announced that its lead compound PLG0206 has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for the treatment of prosthetic joint infections (PJI).
PJI is one of the most challenging complications of joint arthroplasty and a serious, life threatening condition with few effective treatment options. The 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.
“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.”
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.
“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.”
Peptilogics will attend the 2018 BIO International Convention next week in Boston. Chief Executive Officer Sanjay Kakkar M.D. will present the company and its pipeline on Tuesday, June 5 at 10:45 a.m. ET (Theater 4, Level 0).
Peptilogics is an early-stage biotechnology company developing a new class of antibiotics with a novel mechanism of action derived from their eCAP (engineered cationic antibiotic peptide) platform for the treatment of multidrug-resistant infections. Through rational design, this technology dramatically amplifies the antimicrobial activity of naturally-occurring peptides while at the same time achieving a strong systemic safety profile. The eCAP platform has the potential to produce antibiotics with broad-spectrum activity with low risk of generating resistance, due to the unique mechanism of action involving the targeted disruption of bacterial membranes. For more information visit: www.peptilogics.com