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Development of a novel immunomodulatory pyridone for the treatment of acute heart damage

Award Number: R43HL145833
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/18/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2022

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Development of a novel immunomodulatory pyridone for the treatment of acute heart damage - Project summary/abstract In the US, ≈160,000 people per year develop heart failure from acute heart damage, mostly from heart attacks. Approximately 50% of them die within 5 years of the heart failure diagnosis. Currently, there are no therapies to prevent the development of heart failure after acute heart damage. A growing body of evidence points at Pirfenidone, a pyridone currently approved for the treatment of a rare disease through an unknown mechanism of action, as a powerful cardioprotective drug. Pirfenidone is a poorly tolerated drug because of its unfavorable pharmacokinetics. Innovative research recently conducted at Washington University in St Louis discovered that Pirfenidone protects the heart through an immunomodulatory effect on B lymphocytes. Pinpointing the cellular target of Pirfenidone, this research created the opportunity to optimize Pirfenidone. We expect that PEGylation of Pirfenidone with small PEG chains (<500 Daltons) will produce a cardioprotective pyridone with favorable pharmacological properties. PEGylation has been shown to be an effective method to improve the pharmacokinetic profile of small molecules. We have shown that PEGylated-Pirfenidone maintains its immunomodulatory effect on B cells in vitro and has prolonged half-life after IV administration in vivo. We have secured IP on PEGylated-Pirfenidone. In this Phase I application, we seek support to optimize the pharmacokinetics of PEGylated Pirfenidone through highly targeted medicinal chemistry modifications and in vivo measurements in mice, and to test the cardioprotective effects of PEGylated Pirfenidone in clinically relevant in vivo murine models of acute heart injury. In Phase II we will refine the properties of the lead PEGylated compound, characterize its cardioprotective effects in large animal models, and perform initial toxicology studies in preparation of Investigational New Drug(IND) application. If successful, this project will produce a first in class immunomodulatory small molecule for the treatment of acute heart damage and for the prevention of injury-induced heart failure. Based on available pre-clinical data on Pirfenidone and on available clinical data on damage induce heart- failure, just in the US such drug would be expected to save >16,000 lives and >3$bn in projected cost of care every year.


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: 2023 ( Subtotal = $0 )
2023	2019	I-CORDIS, LLC	312 OVERHILL RD	BALTIMORE	MD	21210	BALTIMORE CITY	USA	Cardiovascular Diseases Research	000	1	9/12/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	I-CORDIS, LLC	4362 W PINE BLVD	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	000	1	8/29/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	I-CORDIS, LLC	4362 W PINE BLVD	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	000	1	11/6/2019	NEW	$0
2020	2019	I-CORDIS, LLC	4362 W PINE BLVD	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	001	1	9/5/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $276,227 )
2019	2019	I-CORDIS, LLC	4362 W PINE BLVD	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	000	1	9/18/2019	NEW	$276,227
														Subtotal = $276,227

Grand Total All Awards = $276,227

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Development of a novel immunomodulatory pyridone for the treatment of acute heart damage

Award Number: R43HL145833

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/18/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2022

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