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Optimization of an integrin enhancing molecule for the treatment of Duchenne muscular dystrophy

Award Number: R44OD030543
ORGANIZATION: OFFICE OF THE DIRECTOR, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2015
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Optimization of an integrin enhancing molecule for the treatment of Duchenne muscular dystrophy - Abstract Duchenne Muscular Dystrophy (DMD) is a fatal muscle disease with an incidence of 1 in 5000 males. DMD results from mutations in the gene encoding dystrophin, a 427 kDa scaffolding protein responsible for providing a mechanical link between the muscle fiber actin cytoskeleton and laminin in the extracellular matrix. The α7β1 integrin is a transmembrane linkage system in skeletal and cardiac muscle that also links laminin to the actin cytoskeleton. Studies have demonstrated that transgenic and virally mediated overexpression of the α7 integrin alleviates disease progression and improves survival of mouse models of DMD. Loss of the α7 integrin in dystrophin-deficient mdx mice results in severe muscle disease. Together these studies demonstrate that the α7β1 integrin can serve as a surrogate for the loss of dystrophin and is a target for drug-based therapies. The Burkin lab has previously shown treatments with compounds that increase the α7 integrin in dystrophic muscle lead to enhanced muscle regeneration, improved skeletal muscle strength and decreased myofiber damage. In the Phase 2A STTR, Strykagen has shown that treatments with our lead Stryka969 small molecule are safe, on- target, and have beneficial effects for both dystrophic mouse skeletal and cardiac muscle. In this Phase 2B SBIR proposal, we propose to complete IND-enabling Stryka969 tier 2 ADME, organ toxicity, and metabolite profiling studies. We will also assess the serum pharmacokinetics of Stryka969 in both canine and non-human primates. Lastly, we will perform an efficacy study in the large animal GRMD dog model, considered the gold standard animal model for DMD. These studies will scale the therapeutic treatment using Stryka969 in a large animal preclinical model that more closely recapitulates DMD patient skeletal and cardiac disease. Results from this study will move Stryka969, as a first in class α7β1 integrin enhancing molecules, towards IND and clinical trials for patients with DMD.


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: 2025 ( Subtotal = $0 )
2025	2024	STRYKAGEN CORP	1664 N VIRGINIA ST	RENO	NV	89557	WASHOE	USA	Research Infrastructure Programs	000	5	7/1/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $994,272 )
2024	2024	STRYKAGEN CORP	1664 N VIRGINIA ST	RENO	NV	89557	WASHOE	USA	Research Infrastructure Programs	001	5	8/16/2024	NON-COMPETING CONTINUATION	$994,272
2024	2023	STRYKAGEN CORP	1664 N VIRGINIA ST	RENO	NV	89557	WASHOE	USA	Research Infrastructure Programs	000	4	11/15/2023	COMPETING CONTINUATION	$0
														Subtotal = $994,272

Issue Date FY: 2023 ( Subtotal = $958,973 )
2023	2023	STRYKAGEN CORP	1664 N VIRGINIA ST	RENO	NV	89557	WASHOE	USA	Research Infrastructure Programs	000	4	9/15/2023	COMPETING CONTINUATION	$958,973
														Subtotal = $958,973

Grand Total All Awards = $1,953,245

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Optimization of an integrin enhancing molecule for the treatment of Duchenne muscular dystrophy

Award Number: R44OD030543

ORGANIZATION: OFFICE OF THE DIRECTOR, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2015

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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