PIPELINE

Designing and Advancing Peptide Therapeutics with Purpose

Our therapeutic peptide development programs address some of the most challenging clinical problems.

PLG0206, our lead investigational antibiotic peptide candidate for the treatment of periprosthetic joint infection (PJI), has demonstrated potent in vitro and nonclinical activity, and an acceptable safety profile in healthy volunteers in our Phase I study, supporting a potentially best-in-class profile. PLG0206 is currently being evaluated in patients with PJI in an ongoing clinical trial.

Following our early success in obtaining FDA orphan drug designation for PLG0206 for the treatment of PJI and positive data from our Phase I clinical study, we are expanding our clinical development to additional areas. Based on the inherent properties of peptides, combined with our deep experience and platform capabilities, we have the opportunity to pursue a number of therapeutic areas with significant unmet patient needs.

Platform Discovery

Program

Disease Area

Discovery

Preclinical

Phase 1

Clinical POC

PLGAI002

Rare Genetic Disease

Discovery

PLGAI003

Oncology

Discovery

PLGAI004

Oncology

Discovery

Development

Program

Disease Area

Discovery

Preclinical

Phase 1

Clinical POC

PLG0206

Prosthetic joint infection (PJI)

Phase 1

PLG0206

Orthopedic Expansion

Preclinical

PLG0301

Cystic Fibrosis Infection and Inflammation

Preclinical

Lead PROGRAM: PLG0206

for the Treatment of Periprosthetic Joint Infection

PLG0206 is an investigational, broad-spectrum orthopedic anti-infective peptide with potent anti-biofilm activity based on preclinical studies and has been granted FDA Orphan Drug Designation and Qualified Infectious Disease Product (QIDP) status for the treatment of periprosthetic joint infections (PJI). PLG0206 is fast-acting, bactericidal and has a unique mechanism of action for disrupting bacterial cell membranes that directly and selectively targets bacteria and persistent pathogens that produce biofilm and consequently can evade conventional antibiotics. It aims to be a first-in-class engineered peptide with broad-spectrum antibacterial activity that target certain multi-drug resistant bacteria with an acceptable safety profile from Phase 1.

*PLG0206 and other product candidates described on this website are investigational and have not been approved by the FDA or any other regulatory authority for commercial use.

What is a Periprosthetic Joint Infection (PJI)?

  • Total joint replacements are the most common major surgical procedure annually across the globe, affecting increasingly more patients as the population ages and the obesity epidemic worsens.*
  • At any time following surgery, patients can develop a PJI, a serious and life-threatening condition. PJI patients experience a five-year mortality rate of ~25%** and are in desperate need for novel treatment strategies.
  • Standard systemic anti-infectives typically fail due to poor local penetration and development of biofilms that act as a shield to standard anti-infectives. Often, multiple major surgeries, hospital admissions and long-term antibiotic therapy are required to treat the infection. Even with those interventions, the reinfection rate is 23%.***
  • The estimated combined annual hospital costs related to PJI are expected to reach $1.85 billion by 2030.****

Watch Craig Della Valle, MD of Midwest Orthopaedics at Rush, discuss the burden of PJI and the potential of PLG02026 to change the treatment paradigm.

Resources for Healthcare Professionals

Trial Inquiries

Trial Eligibility

Publications

Clinical Guidelines