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Prevention of White Matter Injury in Premature Infants

Award Number: R42HD097911
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2020
PERIOD OF PERFORMANCE END DATE: 09/30/2023

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Prevention of White Matter Injury in Premature Infants - ABSTRACT Up to 30% of low birth weight preterm infants manifest some form of periventricular white matter injury (PWMI) making it the most common form of brain injury affecting premature infants. PWMI is associated with significant morbidity, as affected individuals may have profound intellectual impairment and cerebral palsy. Highlighting the magnitude of PWMI, each year more than 400,000 infants are born prematurely in the United States. Of these infants, 150,000 are born at risk for PWMI, and about 25,000 children per year will develop PWMI. Thus, finding a prevention and treatment for PWMI is of major public health importance. Oligodendrocytes (OLs) are the myelinating cells of the central nervous system and play a critical role in white matter formation. It is believed that loss of Pre-oligodendrocytes (PreOLs), which are proliferative cells that develop into myelinating OLs, plays a major role in PWMI causation. Presently, there are few pharmacological approaches that specifically target PreOLs, resulting in increased proliferation of these cells and increased brain myelination. Medosome Biotec, LLC (MBT) and its research partners at the University of Florida believe a significant market exists to develop and commercialize a therapeutic treatment for white matter injury in premature infants and other brain myelination disorders. To address the shortcomings of current therapeutics, the team, led by Dr. Scott Rivkees (PI) at University of Florida, used high-throughput screening to identify compounds that to stimulate PreOL proliferation. These studies identified 4 compounds as having potential merit. In preliminary studies, we assessed myelination and toxicological properties of these compounds in brain slice and in vivo studies. These studies identified the compound K261- 0298 as the most potent stimulator of myelination. This compound was subsequently tested in short-term and long-term toxicology studies in neonatal mice and found to be non-toxic. This compound also stimulated myelination in neonatal mice. Building on our promising data, the proposed STTR fast-track application will first focus on testing this compound for efficacy in models of white matter injury in the Phase1 component. If protective, as anticipated, in the Phase 2 component, we will be to perform IND-enabling studies that will lead to an IND and clinical studies. To achieve these goals, our team will include Drs. Avery and McCardy, who direct the University of Florida Translational Drug Development Core; Charles River and ChemDiv Laboratories, which are CROs with extensive experience in the execution of pre-IND testing; and Pharmlex which has more than 10 years of experience in assisting a pharmaceutical companies in the United States and around the world to bring new therapeutics to the marketplace. This project presents an excellent opportunity to commercialize novel approaches for treating and preventing white matter injury in the tens of thousands of premature infants born and hospitalized each year. As such, we have the opportunity to develop new therapeutics for a huge unmet need.


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: 2024 ( Subtotal = $0 )
2024	2021	MEDOSOME BIOTEC LLC	3416 S ASHWOOD DR	BLOOMINGTON	IN	47401	MONROE	USA	Child Health and Human Development Extramural Research	000	3	3/14/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	MEDOSOME BIOTEC LLC	3416 S ASHWOOD DR	BLOOMINGTON	IN	47401	MONROE	USA	Child Health and Human Development Extramural Research	000	3	5/25/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	MEDOSOME BIOTEC LLC	3416 ASHWOOD DR	BLOOMINGTON	IN	47401	MONROE	USA	Child Health and Human Development Extramural Research	000	3	3/21/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $700,593 )
2021	2021	MEDOSOME BIOTEC LLC	3416 ASHWOOD DR	BLOOMINGTON	IN	47401	MONROE	USA	Child Health and Human Development Extramural Research	000	3	5/20/2021	NON-COMPETING CONTINUATION	$700,593
														Subtotal = $700,593

Issue Date FY: 2020 ( Subtotal = $993,274 )
2020	2020	MEDOSOME BIOTEC LLC	3416 ASHWOOD DR	BLOOMINGTON	IN	47401	MONROE	USA	Child Health and Human Development Extramural Research	000	2	5/14/2020	EXTENSION WITH OR WITHOUT FUNDS	$993,274
2020	2019	MEDOSOME BIOTEC LLC	3416 ASHWOOD DR	BLOOMINGTON	IN	47401	MONROE	USA	Child Health and Human Development Extramural Research	001	1	9/5/2020	NEW	$0
														Subtotal = $993,274

Issue Date FY: 2019 ( Subtotal = $223,899 )
2019	2019	MEDOSOME BIOTEC LLC	3416 ASHWOOD DR	BLOOMINGTON	IN	47401	MONROE	USA	Child Health and Human Development Extramural Research	000	1	5/16/2019	NEW	$223,899
														Subtotal = $223,899

Grand Total All Awards = $1,917,766

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Prevention of White Matter Injury in Premature Infants

Award Number: R42HD097911

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2020

PERIOD OF PERFORMANCE END DATE: 09/30/2023

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