Rebiotix -Model RBX7455 -Microbiota Based Product for Clinical Evaluation
Rebiotix Inc., a Ferring Company, has leveraged its clinical, manufacturing and regulatory experience with RBX2660 to develop the first of its kind non-frozen, room temperature stable oral microbiota-based formulation under the MRT™ drug platform, known as RBX7455. While it is currently used to reduce the incidence of recurrent Clostridioides difficile infection, additional indications are currently under investigation.
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About RBX7455 for rCDI
- Oral MRT will enable easier application for repeat dosing
- Lyophilized formulation
- Room temperature stability
- Broad spectrum gut microbiota
- Master File submitted to the U.S. Food and Drug Administration
- First human clinical study completed in Q2 2018
The findings from this initial study in rCDI were published in Clinical Infectious Diseases in 2020; read the full clinical study outcomes including microbiome analyses here.