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

Award Number: R44DK136463
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2024
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	CERIA THERAPEUTICS INC	1230 N CHERRY AVE	TUCSON	AZ	85721	PIMA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/3/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $1,034,376 )
2025	2025	CERIA THERAPEUTICS INC	1230 N CHERRY AVE	TUCSON	AZ	85721	PIMA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	2/17/2025	NON-COMPETING CONTINUATION	$1,034,376
														Subtotal = $1,034,376

Issue Date FY: 2024 ( Subtotal = $1,006,408 )
2024	2024	CERIA THERAPEUTICS INC	1230 N CHERRY AVE	TUCSON	AZ	85721	PIMA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/15/2024	NEW	$1,006,408
														Subtotal = $1,006,408

Grand Total All Awards = $2,040,784

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

Award Number: R44DK136463

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2024

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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