LBP-EC01 / Locus Biosciences - LARVOL DELTA

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) (clinicaltrials.gov) - P2 | N=318 | Recruiting | Sponsor: Locus Biosciences | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Infectious Disease • Nephrology • CAT

Armed Phages: A New Weapon in the Battle Against Antimicrobial Resistance. (PubMed, Viruses) - "SNIPR001 has completed a Phase I clinical trial evaluating safety in healthy volunteers, while LBP-EC01 is in Phase II trials assessing its performance in the treatment of Escherichia coli-induced urinary tract infections in patients with a history of drug-resistant infections. As "armed phages" progress toward clinical application, they hold great promise for precision-targeted antimicrobial therapies and represent a critical innovation in addressing the global antibiotic resistance crisis."

Journal • Review • Infectious Disease • Nephrology

Safety, pharmacokinetics, and pharmacodynamics of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage cocktail, in uncomplicated urinary tract infections due to Escherichia coli (ELIMINATE): the randomised, open-label, first part of a two-part phase 2 trial. (PubMed, Lancet Infect Dis) - P2 | "A regimen consisting of 2 days of intraurethral LBP-EC01 and 3 days of concurrent intravenous LBP-EC01 (1 × 1010 PFU) and oral TMP-SMX twice a day was well tolerated, with consistent pharmacokinetic profiles in urine and blood. LBP-EC01 and TMP-SMX dosing resulted in a rapid and durable reduction of E coli, with corresponding elimination of clinical symptoms in evaluable patients. LBP-EC01 holds promise in providing an alternative therapy for uncomplicated UTIs, with further testing of the group A dosing regimen planned in the controlled, double-blind, second part of ELIMINATE."

Journal • P2 data • PK/PD data • Cardiovascular • Infectious Disease • Nephrology

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) (clinicaltrials.gov) - P2 | N=318 | Recruiting | Sponsor: Locus Biosciences | Phase classification: P2/3 ➔ P2 | N=580 ➔ 318

Enrollment change • Phase classification • Infectious Disease • Nephrology • CAT

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Multi-drug Resistant E. Coli (ELIMINATE Trial) (clinicaltrials.gov) - P2/3 | N=580 | Recruiting | Sponsor: Locus Biosciences

New P2/3 trial • Infectious Disease • Nephrology • CAT

[VIRTUAL] Phase 1b Results of Pharmacokinetics, Pharmacodynamics, and Safety for LBP-EC01, a CRISPR-Cas3 Enhanced Bacteriophage Cocktail Targeting Escherichia coli that Cause Urinary Tract Infections (IDWeek 2021) - "LBP-EC01 has proved to be safe and well-tolerated in this Phase 1b study of subjects colonized by E. coli. In addition, phage amplification was observed in patients with E. coli isolates sensitive to LBP-EC01, demonstrating a clear proof of mechanism. Finally, the apparent difference in PD effect between LBP-EC01 and placebo which was irrespective of MDR status, provides promise that LBP-EC01 may someday be an excellent option for patients suffering from UTIs caused by E. coli, especially in strains that are resistant to conventional antibiotics."

Clinical • P1 data • PK/PD data • Infectious Disease

[VIRTUAL] Completion of phase 1b clinical testing of the first CRISPR-engineered bacteriophage product, LBP-EC01 (ECCMID 2021) - No abstract available

Clinical • P1 data

Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Locus Biosciences; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Nephrology

Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: Locus Biosciences; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Nephrology

Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Locus Biosciences; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Nephrology

Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Locus Biosciences; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Locus Biosciences; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open