Title: “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”
https://www.thelancet.com/article/S1473-3099(24)00424-9/abstract
Summary:
This study aimed to determine a safe and effective dosing regimen for LBP-EC01, a novel bacteriophage therapy for uncomplicated urinary tract infections (UTIs) caused by E. coli.
Key Findings:
- Dosing: Researchers tested different combinations of intraurethral and intravenous LBP-EC01 administration along with oral antibiotics (TMP-SMX).
- Safety: The treatment was well-tolerated with no serious side effects. Some participants receiving higher intravenous doses experienced non-serious tachycardia and chills.
- Efficacy: LBP-EC01, combined with antibiotics, showed a rapid and sustained reduction in E. coli levels in the urine and complete resolution of UTI symptoms in evaluable patients.
- Next Steps: The regimen with the lowest intravenous dose (2 x 10^10 PFU) will be further tested in a controlled,double-blinded Phase 2 trial (Part 2).
Additional Points:
- The study involved 39 women with a history of recurrent UTIs.
- The trial was stopped early due to a safety concern regarding higher intravenous doses.
- LBP-EC01 offers promise as an alternative therapy for UTIs, potentially reducing reliance on antibiotics.
Limitations:
- This was a small, open-label trial, meaning participants and researchers knew which treatment was given.
- More research is needed to confirm these findings in a larger, controlled setting.
Overall, this study provides encouraging initial data for LBP-EC01 as a potential treatment for UTIs. Further research is ongoing to confirm its safety and efficacy.
PHAGElogist 