# A Novel Anti-inflammatoryand Anti-oxidant Therapy for Treating Non-healing Diabetic Foot Ulcers

> **NIH NIH R44** · CERIA THERAPEUTICS, INC. · 2024 · $1,006,408

## Abstract

SUMMARY
 Delayed or impaired wound healing is a serious complication of diabetes, often leading to lower limb
amputations. By 2050, 1 in 3 Americans will develop diabetes, and up to 34% of diabetic patients will develop a
diabetic foot ulcer (DFU) in their lifetime. Current treatments for DFUs include debridement, infection control,
maintaining a moist wound environment, and pressure offloading. Despite these interventions, a large number
of DFUs fail to heal and are associated with a cost that exceeds $31 billion annually. Chronic inflammation and
increased oxidative stress have been implicated in the pathogenesis of the diabetic wound healing impairment.
We have designed and tested a new therapeutic that synergistically targets both inflammation and oxidative
stress using novel cerium oxide nanoparticles (CNP), which possess reactive oxygen species (ROS) scavenging
properties, conjugated with an anti-inflammatory microRNA mimic (miR146a) that is deficient in diabetic wounds
and inhibits the activation of NFκB-induced pro-inflammatory response. Importantly, our novel patented
conjugate CNP-miR146a efficiently delivers miR146a into the wound to reduce inflammation and ROS, and
accelerate wound healing.
 We have developed a CNP-miR146a specifically formulated for intradermal injection (CTX-001) for the
treatment of DFUs. Our preliminary studies demonstrate that a one-time intradermal administration of CTX-001
to full-thickness wounds fully corrects the wound healing impairment in diabetic mice and elicits a significant 25%
improvement in wounds in diabetic pigs, essentially by normalization of inflammation and oxidative stress.
Repeated weekly administration can correct the diabetic wound healing impairment, similar to healing in non-
diabetic wounds. Following a Pre-IND meeting with the FDA and having completed a pilot bulk drug substance
cGMP manufacturing of CTX-001, the objective of this Direct to Phase II application by Ceria Therapeutics
(Ceria) is to complete cGMP-grade manufacturing and analysis of CTX-001 drug product (Specific Aim 1) to fulfill
IND-enabling studies. Specific Aim 2 will confirm the preclinical efficacy of CTX-001 in diabetic (Db/Db) mice and
a porcine model of diabetic wound healing; we will assess the role of infection on the efficacy of CTX-001 in
mice, and optimize the dose and frequency of administration of CTX-001 to enhance efficacy in the correction of
the impaired healing in diabetic pigs. In Specific Aim 3, we will carry out a dose-range finding acute toxicity study
of CTX-001 in both rats and minipigs, followed by IND-enabling repeat dose toxicology studies. In vitro
genotoxicity studies and an irritation/sensitization study in guinea pigs will complete safety studies in preparation
for First-in-Human clinical trials with our lead product.

## Key facts

- **NIH application ID:** 10815643
- **Project number:** 1R44DK136463-01A1
- **Recipient organization:** CERIA THERAPEUTICS, INC.
- **Principal Investigator:** David Jackson
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,006,408
- **Award type:** 1
- **Project period:** 2024-02-01 → 2026-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10815643

## Citation

> US National Institutes of Health, RePORTER application 10815643, A Novel Anti-inflammatoryand Anti-oxidant Therapy for Treating Non-healing Diabetic Foot Ulcers (1R44DK136463-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10815643. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*