PLG0206 / Peptilogics - LARVOL DELTA

RETAIN: Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty (clinicaltrials.gov) - P2/3 | N=240 | Recruiting | Sponsor: Peptilogics | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Orthopedics • Pain

RETAIN: Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty (clinicaltrials.gov) - P2/3 | N=240 | Not yet recruiting | Sponsor: Peptilogics

New P2/3 trial • Infectious Disease • Orthopedics • Pain

Antibiotics and non-traditional antimicrobial agents for carbapenem-resistant Acinetobacter baumannii in Phase 1, 2, and 3 clinical trials. (PubMed, Expert Opin Investig Drugs) - "Specifically, 9 antibiotics are in Phase 1 (R-327, xeruborbactam/QPX-7728, upleganan/SPR-206, MRX-8, QPX-9003, zifanocycline/KBP-7072, apramycin/EBL-1003, zosurabalpin/RG-6006, and ANT-3310), two in Phase 2 (BV-100, OMN-6), and two in Phase 3 (zidebactam/WCK-5222, funobactam/XNW-4107) clinical trials...In particular, two monoclonal antibodies (TRL-1068, CMTX-101), a phage therapy (Phagebank), an immune-modulating agent (recombinant human plasma gelsolin/Rhu-pGSN), a microbiome-modulating agent (SER-155), and an engineered cationic antibiotic peptide (PLG-0206). Several agents with promising characteristics against CRAB infections are in clinical development (Phases 1, 2, and 3). The urgent need for therapeutic options against CRAB infections necessitates optimizing efforts and time for introducing successfully studied agents into clinical practice."

Journal • Review • Infectious Disease • GSN

Antibiotics and non-traditional antimicrobial agents for pseudomonas aeruginosa in clinical phases 1, 2, and 3 trials. (PubMed, Expert Opin Investig Drugs) - "Traditional agents in clinical development include β-lactam/β-lactamase inhibitors (funobactam, taniborbactam, QPX2014-xeruborbactam), aminoglycosides (apramycin), polymyxin derivatives (upleganan, MRX-8, and SPR741), fluoroquinolones (MP-376), and lipopolysaccharide transport inhibitors (murepavadin). Non-traditional antibiotics in clinical development include anti-virulence agents (fluorothiazinone), monoclonal antibodies (INFEX-702, TRL-1068, and CMTX-101), bacteriophages (AP-PA02, YPT-01, BX004-A, and WRAIR-PAM-CF1), and miscellaneous agents (AR-501, PLG-0206, SNSP-113, OligoG CF-5/20, and ALX-009). A considerable number of antimicrobial agents, some with novel mechanisms of action, are in clinical phases of development for treating Pseudomonas aeruginosa infections. The urgent need for more therapeutic options necessitates the rapid optimization of progress to introduce new agents into clinical practice."

Journal • Review • Infectious Disease

Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA) (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Peptilogics | Recruiting ➔ Completed | Phase classification: P1b ➔ P1

Phase classification • Trial completion • Infectious Disease • Orthopedics • Pain

"PLG0206 is an investigational, broad-spectrum, anti-biofilm, anti-infective peptide therapeutic currently in clinical development for the treatment of PJI. PLG0206 is supported by @CARB_X. #ECCMID2023" (@damidefelice)

Clinical

Activity of the Novel Engineered Antimicrobial Peptide PLG0206 Against Staphylococci and Enterococci (IDWeek 2022) - No abstract available

Infectious Disease

Activity of the Novel Engineered Antimicrobial Peptide PLG0206 Against Enterobacterales isolates (IDWeek 2022) - No abstract available

Infectious Disease

Engineered peptide PLG0206 overcomes limitations of a challenging antimicrobial drug class. (PubMed, PLoS One) - "PLG0206 displays activity in diverse animal infection models following both systemic (urinary tract infection) and local (prosthetic joint infection) administration. These findings support continuing clinical development of PLG0206 and validate use of rational design for peptide therapeutics to overcome limitations associated with difficult-to-drug pharmaceutical targets."

Journal • Infectious Disease • Nephrology

Evolved resistance to a novel cationic peptide antibiotic requires high mutation supply. (PubMed, Evol Med Public Health) - "The engineered cationic antimicrobial peptide WLBU2 (also known as PLG0206) is a promising broad-spectrum antimicrobial compound that has completed Phase I clinical studies...More surprisingly, mutations that increase aggregation such as the wsp pathway were also selected despite the ability of WLBU2 to kill cells growing in a biofilm. The results show how experimental evolution and WGS can identify genetic targets and actions of new antimicrobial compounds and predict pathways to resistance of new antibiotics in clinical practice."

Journal • Infectious Disease

PLG0206, a novel engineered antibacterial peptide, has broad-spectrum activity against bacteria, including ESKAPE pathogens (ECCMID 2022) - No abstract available

Resistance development to PLG0206, a novel engineered antimicrobial peptide (ECCMID 2022) - No abstract available

Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA) (clinicaltrials.gov) - P1b | N=14 | Recruiting | Sponsor: Peptilogics | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2022 ➔ Apr 2022

Enrollment open • Trial initiation date • Infectious Disease • Orthopedics • Pain

The Engineered Antibiotic Peptide PLG0206 Eliminates Biofilms and Is a Potential Treatment for Periprosthetic Joint Infections. (PubMed, Antibiotics (Basel)) - "PLG0206 has rapid and broad-spectrum activity against both Gram-positive and Gram-negative bacteria that are implicated as etiologic agents in periprosthetic joint infections, including multidrug-resistant ESKAPE pathogens and colistin-resistant isolates. Studies are planned to determine the efficacy of PLG0206 in patients for the treatment of periprosthetic joint infections. This review summarizes the chemistry, pharmacology, and microbiology of PLG0206 and explores its current preclinical, clinical, and regulatory status."

Journal • Review • Infectious Disease

Peptilogics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Trial of PLG0206 in Periprosthetic Joint Infection (Businesswire) - "Phase 1b clinical trial slated to begin enrolling in the first quarter of 2022....Peptilogics...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....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.'"

Enrollment status • IND • Cystic Fibrosis • Infectious Disease

Peptilogics Receives Award from the Cystic Fibrosis Foundation to Investigate PLG0301 and PLG0206 as Potential Dual-Acting Treatments for Lung Infections Associated with Cystic Fibrosis (Businesswire) - "Peptilogics...today announced that the company received an award from the Cystic Fibrosis Foundation. The award will support preclinical research in a new class of engineered antibacterial peptides intended to serve as the first line of defense against invading pathogens, particularly bacteria, including multidrug resistant isolates that live in the airways of the lungs of cystic fibrosis (CF) patients and resist common antibiotic treatments....The preclinical research will focus on PLG0301 and PLG0206, two engineered cationic antibacterial peptides being developed by Peptilogics....The award provided by the Cystic Fibrosis Foundation will generate both in vitro and in vivo data about PLG0301 and PLG0206, which may potentially support an Investigational New Drug (IND) application with the FDA for its continued development."

Financing • Preclinical • Cystic Fibrosis