Peptilogics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Trial of PLG0206 in Periprosthetic Joint Infection
PITTSBURGH--(BUSINESS WIRE)--Jan 10, 2022--
Peptilogics, a biotech company that engineers peptide therapeutics to radically improve the treatment landscape for patients with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) for PLG0206 to treat periprosthetic joint infection (PJI) allowing the Phase 1b study to proceed.
Peptilogics will evaluate the safety and efficacy of PLG0206 in a Phase 1b open-label, dose-escalating study in patients undergoing debridement, antibiotics and implant retention (DAIR) surgery for the treatment of PJI occurring after total knee arthroplasty (TKA).
“PJI is a devastating condition with limited treatment options, since systemic antibiotics frequently fail to eliminate the infection and surgery to remove the infected hardware is then required,” said Jonathan Steckbeck, Ph.D., Founder and CEO of Peptilogics. “Based on our promising preclinical efficacy and healthy volunteer Phase 1 study data with PLG0206, we are excited to explore its safety and efficacy as a potential treatment for patients with PJI.”
PLG0206 is an investigational broad-spectrum, anti-biofilm, anti-infective peptide therapeutic. The current standard of care for PJI includes numerous high-risk surgical procedures coupled with systemic antibiotic treatment, which are often ineffective due to device-associated biofilms. PLG0206 was designed with a unique mechanism of action that allows it to directly addresses biofilm bacteria and persistent pathogens that evade standard of care antibiotics by targeting and disrupting bacterial membranes to trigger bacterial cell death. PLG0206 has demonstrated best-in-class, rapidly bactericidal, broad-spectrum activity against a variety of pathogens, regardless of resistance phenotype, identified by the World Health Organization and the Centers for Disease Control as critical, urgent or high priority targets. PLG0206 has previously been granted FDA Orphan Drug Designation for the treatment of PJI and has been designated as a Qualified Infectious Disease Product (QIDP) as well.
In December, Peptilogics announced the publication of two peer-reviewed studies on PLG0206. Data from a first-in-human Phase 1 study of PLG0206, published in Antimicrobial Agents and Chemotherapy, showed the investigational therapeutic was safe and well tolerated and has favorable pharmacokinetics when intravenously administered as a single dose. These data were presented in September at ID Week. Data from a clinical proxy study of PLG0206, published in Microbiology Spectrum, showed the investigational therapeutics’ ability to reduce bacteria on chronically infected prosthetic knee joints, which may translate to improved clinical outcomes.
About Periprosthetic Joint Infection (PJI)
More than one million total joint replacements are performed annually in the U.S., a number that is expected to grow to four million annual procedures by 2030 due to an aging and active population. Following joint replacement, 1-2% of patients will develop a PJI, a serious life-threatening condition which often necessitates continuous antibiotic usage and high-risk surgical procedures with limited ability to resolve the infection. The current standard of care has up to a 60% failure rate and results in a substantial number of patient deaths, evidenced by a 25% five-year mortality rate.
Peptilogics engineers peptide therapeutics 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 developing 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, CARB-X, and Founders Fund. For more information about Peptilogics, visit www.peptilogics.com or follow the company on Twitter and LinkedIn.
This research is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from the Wellcome Trust, as administrated by CARB-X. The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of CARB-X or its funders.
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KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL SURGERY HEALTH FDA INFECTIOUS DISEASES CLINICAL TRIALS OTHER HEALTH
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PUB: 01/10/2022 08:00 AM/DISC: 01/10/2022 08:03 AM