Clinical Trial

Disease: Urinary Tract Infections, UTI, (NCT05488340)

Disease info:

Urinary tract infections (UTIs) are bacterial infections affecting the urinary system, which includes the kidneys, ureters, bladder, and urethra. These infections most commonly involve the bladder and urethra, causing inflammation and discomfort. UTIs are the second most common type of infection in the body.

UTIs are generally caused by bacteria, with Escherichia coli (E. coli) being the most common cause. Risk factors like diabetes, bladder catheterization, or spinal cord injuries may increase susceptibility.
UTIs can occur in anyone but are notably more common in women, who are four times more likely to experience them than men. Risk is higher in individuals with conditions such as diabetes, those using catheters, or those with spinal cord injuries.

Symptoms of a UTI include pain or burning during urination, frequent and urgent need to urinate, pressure in the lower abdomen, cloudy or reddish urine, and bad-smelling urine. Less common symptoms may include fever, tiredness, shakiness, back pain, or nausea.

 

Frequency:
UTIs can occur in anyone but are notably more common in women, who are four times more likely to experience them than men. Risk is higher in individuals with conditions such as diabetes, those using catheters, or those with spinal cord injuries.
Official title:
A Phase 2, Double-blind, Randomized, Active-controlled Evaluation of the Safety, Tolerability, Pharmacokinetics and Efficacy of LBP-EC01 in the Treatment of Acute Uncomplicated Urinary Tract Infection Caused by Drug Resistant E. Coli
Who:

Contact

Locus Clinical Operations

Name: Paul Kim

Phone: (919) 495-4510

Email: clinicaloperations@locus-bio.com 

Backup Email: Paul.kim@locus-bio.com

Sponsor:

Locus Biosciences

Partners:

Parexel

Locations:

United States, Florida 

Research Site 102, Doral, Florida, United States, 33166

Research Site 107, Miami, Florida, United States, 33165

Research Site 106, Miami, Florida, United States, 33173

Research Site 103, Miami, Florida, United States, 33176

Research Site 100, Palmetto Bay, Florida, United States, 33157

United States, Texas 
Research Site 108, Forney, Texas, United States, 75126
 

Study start:
Jul. 13, 2022
Enrollment:
318 participants
Gene editing method:
CRISPR-Cas3
Type of edit:
Gene insertion
Gene:
Targets E. coli genome
Delivery method:
Trial link:
https://clinicaltrials.gov/study/NCT05488340?spons=Locus%20Biosciences&rank=1#collaborators-and-investigators
Safety updates:

(12-08-2024) Locus Biosciences Announces Positive Results from Part 1 of ELIMINATE Phase 2 Trial of the Engineered Bacteriophage Therapy LBP-EC01 Published in The Lancet Infectious Diseases

(13-09-2022) Locus Biosciences Announces First Patient Treated in the ELIMINATE Registrational Phase 2/3 Trial of LBP-EC01 for Urinary Tract Infections

Note:
This treatment used CRISPR-engineered bacteriaphage to target E. coli genomes.
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.

This study will consist of two parts.

Part 1 - Dose regimen selection: An open-label, 30 patient, 3-arm PK assessment of: Arm 4 (previously 1): LBP-EC01 (approximately 2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^11 PFU) IV given as a 1 milliliter (mL) bolus QD from D1 through D3 concomitantly with oral trimethoprim/sulfamethoxazole (TMP 160mg/SMX 800mg) BID from D1 through D3 (6 doses); Arm 5 (previously 2): LBP-EC01 (approximately 2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^10 PFU) IV given as a 1 mL bolus QD from D1 through D3 concomitantly with oral TMP/SMX BID from D1 through D3 (6 doses); Arm 6 (previously 3): LBP-EC01 (2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^12 PFU) IV given as a 100 mL IV infusion over 2 h on D1 through D3 concomitantly with oral TMP/SMX BID from D1 through D3 (6 doses).

Part 2 - Efficacy, Safety, Tolerability and Pharmacokinetics: A blinded, 288 patient, 1:1 randomized evaluation of the Arm 4 dose regimen, selected from Part 1, versus placebo + antibiotic (TMP/SMX -160 mg TMP and 800 mg SMX) given orally BID on Days 1 through 3.

Last updated: Jan. 9, 2025
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