Drug intelligence / Profile preview

EDP1815

Development stage
Phase 3
Lead developer
Evelo Biosciences
Modality
Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
Administration
Oral
01

Overview

EDP1815 is an investigational **oral, gut-restricted microbial therapy** developed by Evelo Biosciences for inflammatory diseases, especially **psoriasis** and **atopic dermatitis**. It is a **non-live, non-colonizing pharmaceutical preparation of a single strain of *Prevotella histicola*** isolated from the duodenum of a human donor and formulated as enteric oral capsules. The program was designed to act in the **small intestinal axis** to modulate systemic inflammation without systemic drug exposure, gut colonization, or meaningful alteration of the resident microbiome. Preclinical and early clinical studies suggested broad anti-inflammatory activity across **Th1-, Th2-, and Th17-mediated inflammation**, with placebo-like tolerability. In Phase 1b studies, signals of activity were reported in psoriasis, atopic dermatitis, and a KLH skin-challenge model in healthy volunteers. However, a Phase 2 atopic dermatitis study failed to meet its primary endpoint across cohorts, and Evelo announced in April 2023 that it would **cease further development in atopic dermatitis**. The asset was also advanced in psoriasis, where company communications described positive Phase 2 data and a potential path toward registration-trial design, but no approved product or nonproprietary name has been identified.

02

Targets

TLR2 (Toll-like Receptor 2)

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