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AG011

Development stage: Phase 2
Lead developer: ActoBio Therapeutics
Modality: Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration: Oral, Rectal

Overview

AG011 is an ActoGeniX microbial therapeutic candidate for inflammatory bowel disease, formulated as a genetically modified *Lactococcus lactis* engineered to secrete human interleukin-10 locally in the intestine. The program was developed to deliver IL-10 directly at inflamed gut mucosa in ulcerative colitis and Crohn's disease with the goal of increasing local anti-inflammatory activity while reducing the systemic adverse effects seen with injected cytokine therapy. Publicly described clinical testing included a Phase 2a randomized placebo-controlled study in moderately active ulcerative colitis using capsule plus rectal enema administration for 28 days; ActoGeniX reported that primary endpoints related to safety, tolerability, environmental containment, and biomarker assessment were met, but the study did not show a statistically significant mucosal-healing benefit versus placebo.

Other names: genetically modified Lactococcus lactis secreting human interleukin-10clinical formulation of a genetically modified L. lactis engineered to secrete human interleukin-10

Targets

IL10RA (Interleukin-10 Receptor)

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