Drug intelligence / Profile preview

RBX2660 + RBX7455

Development stage
Phase 1
Lead developer
Ferring Pharmaceuticals
Modality
Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
Administration
Oral, Rectal
01

Overview

RBX2660 + RBX7455 is a combination microbiota-based therapeutic regimen being evaluated for the treatment of active pediatric Crohn's disease. RBX2660 (brand name Rebyota) is a broad-spectrum, human-derived fecal microbiota suspension designed for rectal administration via colonoscope or enema. RBX7455 is a room-temperature stable, orally administered microbiota capsule formulation. Both products are developed by Rebiotix, a Ferring Pharmaceuticals company, and are classified as live biotherapeutic products. The therapy aims to restore a diverse and functional gut microbiome to counteract the dysbiosis associated with Crohn's disease, thereby modulating the host immune system and reducing intestinal inflammation. The PediCRaFT pilot study, conducted at McMaster Children's Hospital, investigates the feasibility and efficacy of an induction dose of RBX2660 followed by a six-week maintenance course of RBX7455.

Other names
PediCRaFT FMTFecal Microbiota TransplantFMToral microbiota capsulesOMC

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