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Development of Reconstituted High-Density Lipoprotein Nanoparticles for Targeted Delivery of Neuroprotective Agents to Retinal Ganglion Cells

Award Number: F31EY035916
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: FELLOWSHIP/SCHOLARSHIP/STUDENT LOANS
PERIOD OF PERFORMANCE START DATE: 05/01/2024
PERIOD OF PERFORMANCE END DATE: 04/30/2026
AWARD TERMINATION DATE: 02/19/2026

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Development of Reconstituted High-Density Lipoprotein Nanoparticles for Targeted Delivery of Neuroprotective Agents to Retinal Ganglion Cells - Project Summary/Abstract Glaucoma is a vision-threatening condition that affects millions of people worldwide, and current treatment options are limited in their efficacy. While reducing intraocular pressure is the most commonly used approach, it does not address neurodegeneration and loss of retinal ganglion cells (RGCs) that ultimately lead to blindness. To address these challenges, we propose a novel approach that utilizes reconstituted high-density lipoprotein (rHDL) nanoparticles, which have been shown to target specific cell types mediated by their binding to the scavenger receptor class B1 (SR-B1) to deliver lipophilic drugs to RGCs. Our laboratory has extensive experience with developing strategies for neuroprotection in glaucoma, particularly, targeting the endothelin system in the retina. Our published work demonstrates that the FDA-approved drug macitentan, a pan-endothelin receptor antagonist elicits neuroprotective effects on RGCs by inhibiting pro-apoptotic JNK signaling when dosed orally in rat Morrison's model of ocular hypertension. Our approach involves the encapsulation of macitentan in rHDL nanoparticles for delivery to RGCs via their interaction with the SR-B1 receptors. To further increase specificity of delivery to RGCs, our rHDL nanoparticles will be linked to a cholera toxin B subunit (CTB) through conjugation with a fatty acid residue, generating a custom- made molecule that will bind to enriched gangliosides present on RGCs. Our three specific aims are to: (1) create and optimize the rHDL-ApoAI-CTB (rHAC) nanoparticles loaded with macitentan, (2) optimize the delivery and release of macitentan from the nanoparticles, and (3) investigate the neuroprotective mechanisms of macitentan when delivered intracellularly into RGCs. By targeting both the SR-B1 receptor and gangliosides, we can ensure that the neuroprotective drug will deliver specifically to RGCs. rHDL-CTB nanoparticles have the ability to cross biological barriers and selectively target RGCs. In addition, we believe that use of macitentan as a neuroprotective agent has the potential to slow the neurodegenerative processes in glaucoma. Our approach has the potential to significantly improve the specificity and efficacy of glaucoma treatments and could ultimately reduce vision loss resulting from this condition. Ultimately, our strategy has the potential to significantly improve patient outcomes and reduce healthcare costs associated with glaucoma treatments.


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	THE UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Vision Research	000	2	2/19/2026	TERMINATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $36,456 )
2025	2025	THE UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Vision Research	000	2	5/28/2025	NON-COMPETING CONTINUATION	$36,456
														Subtotal = $36,456

Issue Date FY: 2024 ( Subtotal = $35,892 )
2024	2024	THE UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Vision Research	002	1	6/13/2024	NEW	$1,280
2024	2024	THE UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Vision Research	001	1	12/21/2023	NEW	$0
2024	2024	UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Vision Research	000	1	12/21/2023	NEW	$34,612
														Subtotal = $35,892

Grand Total All Awards = $72,348

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Development of Reconstituted High-Density Lipoprotein Nanoparticles for Targeted Delivery of Neuroprotective Agents to Retinal Ganglion Cells

Award Number: F31EY035916

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: FELLOWSHIP/SCHOLARSHIP/STUDENT LOANS

PERIOD OF PERFORMANCE START DATE: 05/01/2024

PERIOD OF PERFORMANCE END DATE: 04/30/2026

AWARD TERMINATION DATE: 02/19/2026

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