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pp-196

Oral solution

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Urinary tract infections (UTI) caused by E. coli — including multidrug-resistant strains; Clinical stage: Phase 2/3 — ELIMINATE trial ongoing Modality: Biological (CRISPR-Cas3-engineered precision bacteriophage cocktail — NBE) Mechanism / Target: Cocktail of engineered lytic bacteriophages containing CRISPR-Cas3 bacterial chromosome-degrading payload; specifically targets and eliminates E. coli (including MDR strains) without disrupting commensal microbiome; CRISPR-Cas3 is mutation-resistant (degrades entire chromosome) Route / form: Oral / intravesical delivery Differentiation: First CRISPR-engineered precision phage therapy in Phase 2/3; targets multidrug-resistant E. coli UTI — a major antibiotics-resistance crisis;
Manufacturer #39335
US-based clinical-stage biotech developing Rx engineered biotherapeutics for drug-resistant bacterial infections and related areas. A proprietary precision platform advances lead programs through mid-stage clinical trials. Operates global development partnerships addressing antimicrobial resistance.

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