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Development of a Novel Immunomodulatory Pyridone for the Treatment of Heart Failure with Preserved Ejection Fraction

Award Number: R44HL145833
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: 08/31/2025

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Development of a Novel Immunomodulatory Pyridone for the Treatment of Heart Failure with Preserved Ejection Fraction - PROJECT SUMMARY/ABSTRACT Heart Failure with preserved Ejection Fraction (HFpEF) is one of the major drivers of healthcare costs in the western world and arguably the largest unmet need in cardiology. Currently, there are no FDA approved drugs to treat the vast majority of patients with HFpEF. Recently, the Phase II PIROUETTE trial showed that the immunomodulatory drug pirfenidone, marketed for the treatment of a rare lung disease, has marked beneficial effects in patients with HFpEF. Unfortunately, pirfenidone is a suboptimal drug. In fact, because of its poor pharmacokinetics, patients need to take 2 large pills three times a day and they often develop mild to moderate side effects that lead to dose reduction or discontinuation of treatment (38% of treated patients had to discontinue pirfenidone in the PIROUETTE trial). Moreover, from a commercial point of view, pirfenidone has no intellectual property protection and therefore pharmaceutical companies have no incentive to develop it for further applications. i-Cordis has PEGylated pirfenidone to obtain “Pegydone”, a new molecular entity with better exposure, less toxicity and superior therapeutic effects than pirfenidone. i-Cordis has completed proof of concept studies in rodent models. In this SBIR Phase II grant i-Cordis requests support to complete critical pre-clinical studies to de-risk its drug development effort in the eyes of potential investors. Following completion of the Phase II grant, the company plans to raise dilutive funding to complete IND filing, and progress through clinical trials, FDA approval and commercialization of Pegydone as a prescription drug for the treatment of HFpEF.


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	2023	I-CORDIS, LLC	312 OVERHILL RD	BALTIMORE	MD	21210	BALTIMORE CITY	USA	Cardiovascular Diseases Research	000	3	10/11/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $739,896 )
2023	2023	I-CORDIS, LLC	312 OVERHILL RD	BALTIMORE	MD	21210	BALTIMORE CITY	USA	Cardiovascular Diseases Research	000	3	8/8/2023	NON-COMPETING CONTINUATION	$739,896
														Subtotal = $739,896

Issue Date FY: 2022 ( Subtotal = $808,812 )
2022	2022	I-CORDIS, LLC	4362 W PINE BLVD	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	000	2	8/2/2022	COMPETING CONTINUATION	$808,812
														Subtotal = $808,812

Grand Total All Awards = $1,548,708

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Development of a Novel Immunomodulatory Pyridone for the Treatment of Heart Failure with Preserved Ejection Fraction

Award Number: R44HL145833

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: 08/31/2025

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