11 January 2022 - - The US Food and Drug Administration has accepted US-based biotechnology company Peptilogics' Investigational New Drug Application for PLG0206 to treat periprosthetic joint infection allowing the Phase 1b study to proceed, the company said.

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 surgery for the treatment of PJI occurring after total knee arthroplasty.

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 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.

More than 1m total joint replacements are performed annually in the US, a number that is expected to grow to four m 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.

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.