Cure8 regulatory brief
This project could introduce a novel, microbiome-targeted oral therapy for Crohn’s disease if the Phase II trial confirms safety and clinical benefit; that matters because many patients need new options when current therapies fail or cause side effects.
Adults with Crohn's disease, clinicians treating IBD, researchers in microbiome and immune therapies, and patients interested in microbiome-targeted or non-systemic treatments.
The project aims to run a proof-of-concept Phase II clinical trial of R-3750 in adults with Crohn’s disease to evaluate safety and clinical efficacy. R-3750 is an oral engineered probiotic designed to support mucosal barrier function, upregulate regulatory T cells, and alter microbiome composition according to the project summary.
The record links this effort to prior Phase 1 testing in mild-to-moderate ulcerative colitis (IND 28994, NCT05666960) and emphasizes a microbiome-targeted, immunologically directed approach rather than a conventional small molecule or biologic drug.
The entry represents a funded SBIR project to move the candidate into a formal Phase II proof-of-concept study.
This record is a NIH Reporter project description (project-record) for a funded SBIR Phase II proposal. It summarizes preclinical findings and prior Phase I UC trial observations but does not present peer-reviewed trial results. Planned Phase II testing is described; outcomes are not reported here.
Review the original publication for the complete reporting, methods, and context.
Funding disclosed by the source: National Institute of Diabetes and Digestive and Kidney Diseases - R44DK146369 - $1,042,478
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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