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Thank you for your interest in the ELIMINATE trial, a Phase 2 study designed to evaluate LBP-EC01 as a treatment for Acute Uncomplicated Urinary Tract Infection caused by drug Resistant E. coli.

If you're interested in participating, please call 833-305-6287 to begin the phone screen.

ELIMINATE Trial

Worldwide, an estimated 150 million people are affected by Urinary Tract Infections (UTIs) each year.  Approximately 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics.  Nearly 40% of patients with UTIs experience a recurrence within months of the first episode.  Both the U.S. Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) have identified antibiotic-resistant E. coli as an urgent and serious public health threat requiring development of new treatments. 

 

To address these critical, unmet medical needs, Locus Biosciences has partnered with the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services, to develop a new class of precision biotherapeutics to treat UTIs and other infections caused by E. coli.

 

LBP-EC01 is a clinical-stage precision investigational therapeutic designed to target E. coli infections.  It is a cocktail of bacteriophages (Phages) engineered to precisely remove E. coli bacteria, which may be resistant to multiple drugs, in patients with UTIs.  This product is currently being evaluated in a clinical trial for the treatment of recurrent, uncomplicated UTIs in women.

 

about Locus Biosciences

about how phages work

about the ELIMINATE trial

Trial Eligibility

You may be eligible for the study if you meet the following criteria:

  1. Female patients from ≥18 years to 70 years of age at Screening. 

  2. Documented history of UTI in the past 12 months and prior or current uUTI caused by antimicrobial (AMR) resistant E. coli (as single pathogen or part of polymicrobial infection where E. coli is the predominant pathogen).  Note that a current infection may be used to meet this inclusion criterion (AMR E. coli documentation).

  3. Able to supply a midstream, clean catch urine sample for microbiological analysis. 

  4. Active acute uUTI infection defined by a AND b:  

a. Evidence of pyuria (presence of white blood cells in the urine)  

b. At least 2 of the following signs or symptoms of UTI

i. Dysuria (pain or burning sensation while urinating)

ii. Urinary urgency

iii. Urinary frequency

iv. Suprapubic pain (near the urinary bladder)

 

You are not eligible for the study if you meet the following criteria:

  1. Signs or symptoms of systemic illness such as fever greater equal to or greater than 100.4°F, shaking chills, or other clinical manifestations suggestive of complicated UTI. 

  2. Treatment with other antibacterial drugs including those that are effective for treatment of the acute UTI or prevention of recurrent UTI in the 5 days prior to Screening, unless the bacteria that are causing the UTI demonstrate resistance to the initial antibiotic and clinical symptoms persist.  In postmenopausal women, vaginal estrogen replacement therapy is permitted so long as all other eligibility criteria are met, the dose and regimen has be stable for > 6 months from Screening, and that there are no planned changes to therapy through the 6-month follow-up period.

  3. Clinical symptoms for more than 5 days before Screening. 

  4. Presence of indwelling urinary bladder catheters, urinary tract anatomical abnormalities, poorly controlled diabetes mellitus, renal calculi, or advanced renal (kidney) dysfunction.

  5. Individual considered to be immunocompromised.

  6. Clinically significant serious unstable physical or mental illness that in the investigator’s opinion prevents patient from completing the study.

  7. Pregnant or nursing.

  8. History of autonomic dysreflexia (a condition that occurs after a spinal cord injury which results in an abnormal, overreaction of the involuntary (autonomic) nervous system to stimulation.).

  9. Patients with incontinence.

  10. Reside in a long-term care facility. 

Recruiting Study Sites

At this time, the study is paused while we are in preparation for Part 2.

If you think you may qualify for the ELIMINATE trial, please call 833-305-6287 to perform an automated pre-screening questionnaire; your information will be retained for future referral to a participating site.

 

Are you a medical professional interested in learning more?  Let us know via the contact form below.  

(* indicates required field)

Thank you for your interest in Locus Biosciences' ELIMINATE study!

Are you an individual interested in participating in the study as a patient?

 

Locus would like to collect information about where patients go for medical care.  Please provide contact information for your current preferred care provider.  (* indicates required field)

Please do not enter personal information about yourself.  Your care provider will not be contacted about you or your possible participation in this study.

Thank you for your interest in Locus Biosciences' ELIMINATE study!

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