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Nezavist a Novel Molecule for Treatment of Alcohol Use Disorder

Award Number: U44AA024905
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/25/2015
PERIOD OF PERFORMANCE END DATE: 08/31/2021

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Nezavist a Novel Molecule for Treatment of Alcohol Use Disorder - DESCRIPTION (provided by applicant): Alcohol Use Disorder affects 7.9% of the U.S. population ages 18 and older and costs society over $223 billion per year in direct medical costs, accidents and lost productivity. Current pharmacotherapy is only modestly effective and has to be used in conjunction with psychosocial treatment. Primary care physicians are ill equipped to provide the currently necessary range of therapy for treating AUD and the modest effects of therapy generate a significant number of treatment failures. We have generated a novel molecule with action directly at one of the major neurotransmitter receptors altered by chronic excessive consumption of alcohol. We have also demonstrated in two different models of relapse drinking by alcohol dependent animals that our medication can reduce or prevent such relapse. Our preliminary studies on the safety and metabolism of our compound in animals provide confidence that the compound will have a good therapeutic index in human clinical trials. Prior to embarking on the trials in humans we, however, need for our drug to be approved for an IND by the Food and Drug Administration. To be able to accomplish this milestone we are proposing a series of SBIR Phase I, IND enabling studies, which include the development of an oral formulation which will be attractive for use with humans; the use of this formulation to repeat the relapse blocking effects of our compound in rats, and to extend our studies on reducing alcohol consumption with our compound to non- human primates. In these SBIR Phase I studies we will also establish the blood and brain levels of our drug after oral administration in the newly developed formulation. In the SBIR Phase II studies we will produce our drug under cGMP conditions and scale up production to meet future clinical trials. The Phase II SBIR studies will be fully focused on completing all of the FDA required studies for the IND, including complete studies of in vitro metabolism and metabolite identification, in vivo studies of Absorption, Distribution, Metabolism, and Excretion, complete studies on safety and toxicology (including toxicokinetics) in two species (rats and monkeys). These studies will include escalating acute dose studies and sub-chronic and chronic studies of up to six months duration because we anticipate that human studies may include long term maintenance of patients on our medication. If an IND designation is obtained we anticipate launching a Phase I human safety trial with an arm of this study aimed at a clinical measure of craving in alcohol-dependent subjects. If this grant is funded and our medication reaches human trials we anticipate introducing a more efficacious and much more highly utilized medication to treat 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: 2022 ( Subtotal = $0 )
2022	2019	LOHOCLA RESEARCH CORP	29 SALEM LN	EVANSTON	IL	60203	COOK	USA	Alcohol Research Programs	001	5	6/15/2022	NON-COMPETING CONTINUATION	$0
2022	2019	LOHOCLA RESEARCH CORPORATION	29 SALEM LN	EVANSTON	IL	60203	COOK	USA	Alcohol Research Programs	000	5	5/27/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $124,401 )
2021	2021	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	000	5	3/5/2021	SUPPLEMENT FOR EXPANSION	$124,401
2021	2019	LOHOCLA RESEARCH CORPORATION	29 SALEM LN	EVANSTON	IL	60203	COOK	USA	Alcohol Research Programs	001	5	8/31/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $124,401

Issue Date FY: 2020 ( Subtotal = $212,652 )
2020	2020	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	000	5	8/26/2020	SUPPLEMENT FOR EXPANSION	$212,652
														Subtotal = $212,652

Issue Date FY: 2019 ( Subtotal = $2,418,712 )
2019	2019	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	003	4	2/28/2019	SUPPLEMENT FOR EXPANSION	$918,712
2019	2019	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	004	5	8/23/2019	NON-COMPETING CONTINUATION	$1,500,000
2019	2017	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	002	3	12/20/2018	EXTENSION WITH OR WITHOUT FUNDS	$35,771
2019	2016	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	001	2	12/20/2018	NON-COMPETING CONTINUATION	-$35,771
2019	2016	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	000	2	10/24/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,418,712

Issue Date FY: 2018 ( Subtotal = $1,500,000 )
2018	2018	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	000	4	8/21/2018	NON-COMPETING CONTINUATION	$1,500,000
														Subtotal = $1,500,000

Issue Date FY: 2017 ( Subtotal = $1,500,000 )
2017	2017	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	001	3	9/12/2017	EXTENSION WITH OR WITHOUT FUNDS	$1,500,000
2017	2016	LOHOCLA RESEARCH CORPORATION	505 CHICAGO AVE	EVANSTON	IL	60202	COOK	USA	Alcohol Research Programs	000	2	9/12/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,500,000

Issue Date FY: 2016 ( Subtotal = $985,777 )
2016	2016	LOHOCLA RESEARCH CORPORATION	1200 Olive St	Denver	CO	80220	DENVER	USA	Alcohol Research Programs	000	2	8/12/2016	NON-COMPETING CONTINUATION	$985,777
														Subtotal = $985,777

Issue Date FY: 2015 ( Subtotal = $1,000,000 )
2015	2015	LOHOCLA RESEARCH CORPORATION	1200 Olive St	Denver	CO	80220	DENVER	USA	Alcohol Research Programs	000	1	9/23/2015	NEW	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $7,741,542

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Nezavist a Novel Molecule for Treatment of Alcohol Use Disorder

Award Number: U44AA024905

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/25/2015

PERIOD OF PERFORMANCE END DATE: 08/31/2021

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