# Phase 1 study of oral epigallocatechin-3-gallate (EGCG) in IPF patients

> **NIH NIH R33** · WEILL MEDICAL COLL OF CORNELL UNIV · 2024 · $48,139

## Abstract

PROJECT SUMMARY / ABSTRACT
The development of additional therapies for idiopathic pulmonary fibrosis is a pressing human health need. We
have identified epigallocatechin-3-gallate (EGCG), as potent (IC50 ~ 50-100 nM) blocker of TGFβ1 responses
ex vivo and new collagen deposition in vivo in the bleomycin model of pulmonary fibrosis. EGCG is a principal
component of green tea and has been utilized in multiple human studies. We have administered EGCG to
patients with pulmonary fibrosis for two weeks prior to undergoing lung biopsy and demonstrated highly
significant reversal of pro-fibrotic markers in lung tissue and decreases in blood biomarkers of TGFβ1
signaling. However, EGCG has not been given to patients with IPF in the setting of concurrent FDA-approved
IPF therapies and determination of the safety of EGCG in the setting of nintedanib or pirfenidone use is
essential given infrequent report of EGCG associated hepatotoxicity. The overarching goal of this proposal is
to define the safety and optimal dose of EGCG in IPF patients. We will use the R61/R33 mechanism to
conduct a robust randomized controlled Phase I trial to obtain additional critical safety and biomarker data
sufficient to empower a Phase II clinical trial to assess the efficacy of EGCG in IPF patients. A total of 5
cohorts of 10 IPF patients each at 6 clinical sites will be enrolled to receive EGCG. In Aim 1, we will determine
the safety of oral 400 mg and 600 mg EGCG given once daily to IPF patients for 12 weeks concurrent with
nintedanib or pirfenidone. We will also determine if 400 mg or 600 mg EGCG impacts nintedanib or pirfenidone
blood levels, and whether these antifibrotics alter the blood levels of EGCG. Clinical safety, especially
hepatotoxicity, will be monitored closely during the 12 week treatment duration and the 4 weeks of follow-up. In
Aim 2, we will measure the change in levels of prespecified serum biomarkers including COMP, Periostin, and
pro-MMP1 with EGCG treatment to determine if there is an in vivo signal for EGCG effect. Lastly, in Aim 3, we
will utilize the type I collagen-specific PET probe, 68Ga-CBP8 to determine the impact of EGCG in attenuating
lung accumulation. The results of Aim 2 and 3 will provide crucial information as to dose selection. This
proposal leverages the expertise of a multi-principal investigator team that are leaders in fibrosis biology and
clinical trial design, a low cost intervention, and an innovative molecular probe. The totality of this information
will provide key information needed to design a phase II with the ultimate goal of developing much needed IPF
therapies.

## Key facts

- **NIH application ID:** 10814928
- **Project number:** 5R33HL158540-03
- **Recipient organization:** WEILL MEDICAL COLL OF CORNELL UNIV
- **Principal Investigator:** Harold A Chapman
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $48,139
- **Award type:** 5
- **Project period:** 2022-05-20 → 2024-06-25

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10814928

## Citation

> US National Institutes of Health, RePORTER application 10814928, Phase 1 study of oral epigallocatechin-3-gallate (EGCG) in IPF patients (5R33HL158540-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10814928. Licensed CC0.

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