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Testing of SCO-116, an NRF2 activator for Fuchs' Dystrophy, in cultured human corneas

Award Number: R43EY038532
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Testing of SCO-116, an NRF2 activator for Fuchs' Dystrophy, in cultured human corneas - ABSTRACT Corneal endothelial cells (CECs) actively pump water out of the stroma and maintain corneal clarity; they are required for vision. CECs do not regenerate, and once lost they are gone forever. Declines in CEC density produce visual deficits and, ultimately, blindness, and for this reason advanced techniques to improve CEC health are a part of the NEI Strategic Plan. Currently, there are no approved medicines to restore CEC function once lost, or to prevent demise of CECs when damaged or dysfunctional. Fuchs’ Corneal Endothelial Dystrophy is a chronic disease of the CEC in which cells do not effectively neutralize oxidative stress resulting in cell damage and death. Kuria Therapeutics is developing a novel product containing the active ingredient SCO-116 that activates NRF2, the master regulator of the antioxidant response system. Through NRF2 activation, it is proposed that CECs will be protected and rescued from oxidative stress and vision will be preserved. The main goal of this Phase 1 application is to obtain proof of concept using cultured human corneas as a model of Fuchs’ to test the efficacy of SCO-116 in activating NRF2 and protecting human CEC. Studies in multiple animal models, including rabbits and monkeys, have indicated significant induction of NRF2 in CECs following treatment with SCO-116. We thus plan to perform studies in cultured human corneas with guttae before Phase 2 testing in preclinical animal studies. The project will be completed through two Specific Aims. In Aim 1, we will test a range of SCO-116 concentrations for the ability to activate NRF2 and induce expression of its target genes. Deceased donor corneas with mild to moderate guttae coverage mimicking Fuchs’ will be cultured with SCO-116 for 5 days and then mRNA will be isolated, converted to cDNA and amplified. Ten NRF2 target genes will be studied along with 2 housekeeping genes for reference. Additionally, the potential effect of SCO-116 treatment on corneal swelling will be studied by daily OCT measurements during treatment. In Aim 2, we will treat donor corneas that have mild to moderate guttae coverage with SCO-116 and assess for a reduction in apoptosis. It has been previously shown that sulforaphane, a natural product NRF2 agonist, reduces apoptosis in the endothelium of Fuchs’ patient corneas. Thus, sulforaphane will be an important comparator in our studies. The anticipated outcome of this proposed project is to produce proof of concept data to support a Phase 2 application where SCO-116 is studied in larger human cornea studies and preclinical animal models of Fuchs’. The overall goal is to test SCO-116 in patients with early Fuchs’ to prevent progression of the disease and potentially reverse the early visual symptoms due to corneal edema.


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 = $306,805 )
2026	2026	KURIA THERAPEUTICS, INC.	9 TRAFALGAR CV	LITTLE ROCK	AR	72210	PULASKI	USA	Vision Research	000	1	9/2/2026	NEW	$306,805
														Subtotal = $306,805

Grand Total All Awards = $306,805

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Testing of SCO-116, an NRF2 activator for Fuchs' Dystrophy, in cultured human corneas

Award Number: R43EY038532

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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