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NOV-001

Development stage: Discontinued
Lead developer: Novome
Modality: Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration: Oral

Overview

**NOV-001** is an investigational orally administered genetically engineered microbial medicine developed by Novome Biotechnologies for enteric hyperoxaluria. It is a combination product comprising NB1000S, a recombinant *Phocaeicola vulgatus* live biotherapeutic engineered with an oxalate-degradation pathway, and NB2000P, a seaweed-derived porphyran prebiotic polysaccharide. NB2000P provides a selective carbon source that enables tunable, reversible gut engraftment of NB1000S; the engrafted bacterium degrades intestinal oxalate, with the objective of reducing oxalate absorption and urinary oxalate excretion, thereby reducing risk of calcium oxalate kidney stones and renal complications. The Phase 1/2a program in enteric hyperoxaluria was terminated after Phase 1/2a clinical evaluation. ([pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40674481/))

Other names: NOV 001NOV001NOV-001

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