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Development of JR-220 (4-Chlorobenzylidenamino-guanidine hydrochloride) as a medication for alcohol dependence

Award Number: U44AA026126
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Development of JR-220 (4-Chlorobenzylidenamino-guanidine hydrochloride) as a medication for alcohol dependence - Abstract The aim of phase I of the parent cooperative agreement (U44AA026126) was to generate sufficient data on the pharmacokinetics (PK) and toxicology (Tox) of JR-220 to support an application for a pre-IND meeting with the FDA. This aim has been successfully accomplished. The aim of phase II of the parent cooperative agreement is to expand the phase I studies with rat and a second species (canine) based upon the feedback of the FDA’s pre-IND meeting response to create a dossier that will be submitted to the FDA in support of IND status for JR-220 as a medication for treatment of alcohol use disorder (AUD). Neither of these aims has changed from the original funded application, but the cost to support several GLP/GMP tasks related to these aims have significantly increased for reasons outside the control of the company. All of these tasks support the potential value of JR-220 as a medication for AUD and are required for IND submission. This administrative supplemental proposal is a request for additional funds to cover the unanticipated increased cost of several key GLP/GMP tasks to be completed that are required by the FDA to submit the IND application. This administrative supplement proposal includes tasks previously proposed and accepted by reviewers and NIAAA. The three key tasks with increased costs are 1) GLP CNS safety study (Neurotoxicity) in rat specifically requested by the FDA in the pre-IND meeting response, 2) cGMP manufacturing of JR-220 (drug substance), and 3) cGMP manufacturing of JR-220 capsules (drug product) for clinical trial. This administrative supplemental request for additional funding under $100K to help cover the incremental unanticipated cost increase from 2016 to completed these original scope tasks is important for the successful completion of the overall goal of the parent cooperative agreement to submit the IND in support of JR-220 as medication for treatment for AUD.


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 = $99,510 )
2024	2024	NAPROGENIX INC	145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	000	5	11/17/2023	SUPPLEMENT FOR EXPANSION	$99,510
2024	2023	NAPROGENIX INC	145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	001	5	7/26/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $99,510

Issue Date FY: 2023 ( Subtotal = $993,323 )
2023	2023	NAPROGENIX INC	145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	002	5	8/29/2023	NON-COMPETING CONTINUATION	$993,323
2023	2022	NAPROGENIX INC	145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	000	4	1/10/2023	NON-COMPETING CONTINUATION	$0
2023	2022	NAPROGENIX INC	145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	001	4	5/26/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $993,323

Issue Date FY: 2022 ( Subtotal = $1,404,983 )
2022	2022	NAPROGENIX INC	145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	001	4	8/20/2022	NON-COMPETING CONTINUATION	$1,404,983
2022	2021	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	000	3	11/11/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $1,404,983

Issue Date FY: 2021 ( Subtotal = $1,016,716 )
2021	2021	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	001	3	8/31/2021	EXTENSION WITH OR WITHOUT FUNDS	$1,016,716
2021	2021	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	003	3	9/22/2021	EXTENSION WITH OR WITHOUT FUNDS	$377,402
2021	2018	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	000	2	7/8/2021	NON-COMPETING CONTINUATION	$0
2021	2018	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	002	2	9/22/2021	NON-COMPETING CONTINUATION	-$377,402
														Subtotal = $1,016,716

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	000	2	8/7/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	000	2	6/10/2019	NON-COMPETING CONTINUATION	$0
2019	2018	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	001	2	6/17/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $794,605 )
2018	2018	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	001	2	8/2/2018	NON-COMPETING CONTINUATION	$794,605
2018	2017	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	000	1	8/2/2018	NEW	$0
														Subtotal = $794,605

Issue Date FY: 2017 ( Subtotal = $672,530 )
2017	2017	NAPROGENIX, INC.	UK-ASTECC 145 GRAHAM AVENUE	LEXINGTON	KY	40506	FAYETTE	USA	Alcohol Research Programs	000	1	8/24/2017	NEW	$672,530
														Subtotal = $672,530

Grand Total All Awards = $4,981,667

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Development of JR-220 (4-Chlorobenzylidenamino-guanidine hydrochloride) as a medication for alcohol dependence

Award Number: U44AA026126

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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