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A novel sshRNA-antimiR combination therapy for accelerating healing of diabetic foot ulcers

Award Number: R43DK121668
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: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2022

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A novel sshRNA-antimiR combination therapy for accelerating healing of diabetic foot ulcers - Abstract ! The objective of this project is to advance the development of a novel approach to healing chronic diabetic foot ulcers (DFUs), which are a major and growing health concern for which existing treatments are often ineffective. Normal wound healing involves a coordinated cascade of events that are stimulated in part by the hypoxia that results from injury to the vasculature at the wound site. These events include angiogenesis, macrophage recruitment, inhibition of apoptosis, and the expansion and mobilization of fibroblasts and keratinocytes for re-epithelialization. In chronic wounds, the normal response to hypoxia is impaired, and many of these cellular processes are hindered. Our approach involves the therapeutic modulation of a protein and a microRNA (miRNA) that are involved in these hypoxia-induced pathways by the use of oligonucleotides acting by two different mechanisms, RNA interference (RNAi) and antisense. RNAi is achieved by use of SomaGenics’ proprietary sshRNA® (synthetic short hairpin RNA) design, which eliminates sense-strand off- target effects and has been shown to be highly effective in treating chimeric mice infected with hepatitis C virus. In previous SBIR-supported work, we identified oligonucleotides that potently inhibit the protein and miRNA targets in vitro and demonstrated that when these RNAs are incorporated into a medicated bandage by a layer-by-layer (LbL) process and applied to full-thickness wounds of diabetic mice, healing is significantly accelerated and regrowth of vasculature is enhanced. Treatment was also shown to increase levels of downstream factors promoting angiogenesis and to increase the mobility of keratinocytes. The lack of a perfect animal model for DFU healing has led to a consensus among researchers that efficacy and safety should be demonstrated in two diabetic animal models before moving to human trials. Therefore, in this new Phase I proposal, we will validate our mouse results in the neuroischemic diabetic rabbit ear model in collaboration with Dr. Aristidis Veves (Beth Israel Deaconess Medical Center and Harvard Medical School), a leading expert in the rabbit ear model and authority on DFU healing in general. We will continue to employ the bio-erodible LbL drug delivery platform that we have adopted in collaboration with Dr. Paula Hammond (MIT), who has developed this platform. If this Phase I is successful as we expect, in Phase II we plan to perform extensive lead optimization and refinement of our LbL delivery method, including further development of chemical modification patterns that stabilize the RNAs against ribonucleases present in the wound bed without compromising potency or introducing undesired immunostimulatory activity. Optimization will also include defining optimal proportions of the two oligonucleotides in the LbL formulation. We will develop a scalable manufacturing process for large-scale production of LbL-formulated bandage material. Finally, preliminary but carefully designed safety/toxicity studies on a third animal model will be performed. !


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: 2023 ( Subtotal = $0 )
2023	2019	SOMAGENICS, INC.	2161 DELAWARE ST STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	5/4/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	SOMAGENICS, INC.	2161 DELAWARE ST STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/5/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	SOMAGENICS, INC.	2161 DELAWARE ST STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	5/7/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $299,985 )
2019	2019	SOMAGENICS, INC.	2161 DELAWARE ST STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/27/2019	NEW	$299,985
														Subtotal = $299,985

Grand Total All Awards = $299,985

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A novel sshRNA-antimiR combination therapy for accelerating healing of diabetic foot ulcers

Award Number: R43DK121668

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: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2022

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