# Non-invasive exfoliome platform to accelerate treatment for gastrointestinal disorders

> **NIH NIH R43** · FOLI BIO INC. · 2024 · $292,375

## Abstract

SUMMARY
Inflammatory Bowel Disease (IBD), composed of Crohn’s disease (CD) and ulcerative colitis (UC), is the most
common chronic inflammatory condition of the gastrointestinal (GI) tract. Over the last decade, the prevalence
of IBD has increased two to three-fold, with incidences as high as 1.3% in US adults, and significant efforts have
been devoted to profiling IBD using multi-omics approaches to understand molecular drivers of disease,
however, there remains major knowledge gaps in the temporal processes regulating inflammatory states in the
gut at disease onset and during flare-ups. In addition, top pharmaceutical companies collectively spent ~$7B on
R&D in 2022 allocated to GI-related diseases but over a third of patients are regularly failing to respond to first
line therapeutic modalities. Therefore, there is a continued demand for novel interventions that are better tailored
to the patient.
 The GI lining is constantly renewed, as ~1010 intestinal epithelial cells are shed into the digesta daily, and
end up into the stool, with the host cells’ DNA and RNA contents. The exfoliome, i.e. the RNA content exfoliated
from host cells, is a valuable tool to gather insights into the gene expression patterns, cellular signatures, and
biological processes occurring in the gastrointestinal tract, making it potentially useful for understanding IBD.,
and providing a non-invasive means to longitudinally profile dynamic processes occurring within the GI tract.
However, numerous technical obstacles prevent direct exfoliome analysis from stool.
 Foli Bio Inc. has developed an innovative technology, called Exfo-seq, to sequence fecal exfoliome in a highly
sensitive and quantitative manner. Exfo-seq is based on a proprietary signal amplification approach and enables
to precisely and robustly quantify the expression level of several thousand of host genes directly from stool RNA.
In this proposed project, Foli Bio aims to validate the functional utility of Exfo-seq using samples collected from
IBD clinical trial. The overarching goal of this project is to generate unprecedented knowledge regarding the
human GI exfoliome at baseline and over time, and examine the local gut immune profile, evaluate heterogeneity
in inflammatory states between individuals, identify early biomarkers, and predict therapeutic response. More
importantly, Foli Bio believes this technology holds great potential as a non-invasive method to transform future
GI drug development and will substantially benefit pharmaceutical companies as well as the larger population of
IBD patients who remain underserved by the current treatment paradigms in IBD.

## Key facts

- **NIH application ID:** 11008414
- **Project number:** 1R43DK141382-01
- **Recipient organization:** FOLI BIO INC.
- **Principal Investigator:** Yiming Huang
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $292,375
- **Award type:** 1
- **Project period:** 2024-09-17 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008414

## Citation

> US National Institutes of Health, RePORTER application 11008414, Non-invasive exfoliome platform to accelerate treatment for gastrointestinal disorders (1R43DK141382-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/11008414. Licensed CC0.

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