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Sustained release of next-generation aptamers to treat wet AMD

Award Number: R43EY029650
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2018
PERIOD OF PERFORMANCE END DATE: 09/29/2020

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Sustained release of next-generation aptamers to treat wet AMD - Abstract Significance: Wet AMD affects 1.2 M Americans and is the leading cause of blindness in those aged 55 or older. Vision improvement from anti-VEGF treatment is neither permanent nor complete, and patients must receive intravitreal injections every 1-2 months, creating a major treatment burden for patients, physicians and payers. Emerging combination therapies could address the efficacy problem, but they do not solve the treatment burden. Sustained release formulation is the most promising means to dramatically reduce injection frequency. While proven for small molecules in other indications, it has not been achieved with standard of care anti-VEGF-A drugs because, as biologics, they are much larger and more fragile, limiting molar dose and stability. Aptamers, a validated modality in AMD treatment, can be just as potent but are much smaller and more stable, and support long-term sustained release formulation. Hypothesis: We can overcome this problem with (1) next-generation aptamers that inhibit all isoforms of VEGF-A as well as SDF-1, and that are 100% modified to yield long-term in vivo stability, (2) formulation in an injectable PLGA matrix to enable 6-month sustained release. Preliminary Data: We have developed Chemically-Augmented Particle Display (CAPD), a novel platform that yields next-gen aptamers with unprecedented affinity, specificity and in vivo stability. PLGA has been FDA- approved for use in the eye, and our team has previously demonstrated its potential with aptamers. Aims: We will develop next-generation aptamers against VEGF-A and SDF-1, and compare their potency to standard of care anti-VEGF-A agents. We will formulate the aptamer in PLGA microparticles to achieve in vitro release profile lasting at least 6 months with minimal burst and high linearity. We will test PK and efficacy in a mouse laser CNV model and a rabbit NV model. We expect to demonstrate sustained in vivo efficacy for 3 months. If successful, this will establish feasibility to yield 6- month durability, and enable subsequent sustained release combination therapies to address both efficacy and treatment burden needs.


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: 2021 ( Subtotal = $0 )
2021	2018	APTITUDE MEDICAL SYSTEMS, INC.	125 CREMONA DR # 100	GOLETA	CA	93117	SANTA BARBARA	USA	Vision Research	000	1	5/3/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	APTITUDE MEDICAL SYSTEMS, INC.	2219 BATH ST	SANTA BARBARA	CA	93105	SANTA BARBARA	USA	Vision Research	000	1	11/14/2018	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $299,693 )
2018	2018	APTITUDE MEDICAL SYSTEMS, INC.	2219 BATH ST	SANTA BARBARA	CA	93105	SANTA BARBARA	USA	Vision Research	000	1	9/18/2018	NEW	$299,693
														Subtotal = $299,693

Grand Total All Awards = $299,693

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Sustained release of next-generation aptamers to treat wet AMD

Award Number: R43EY029650

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2018

PERIOD OF PERFORMANCE END DATE: 09/29/2020

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