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Investigational New Drug (IND)-enabling and Early-Stage Development of Selective, Reversible, Orally Bioavailable ALDH2 inhibitor ANS-00858 to Treat Alcohol Use Disorder.

Award Number: U43AA030689
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: 08/01/2023
PERIOD OF PERFORMANCE END DATE: 07/31/2025

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Investigational New Drug (IND)-enabling and Early-Stage Development of Selective, Reversible, Orally Bioavailable ALDH2 inhibitor ANS-00858 to Treat Alcohol Use Disorder. - PROJECT SUMMMARY Use of alcohol and alcohol use disorder (AUD) remains high in modern American society. It is estimated that in 2020 over half of the adult population (54.9% of those 18 years or older) used alcohol resulting in 27.6 million adult Americans (11%) diagnosed with AUD. The US Centers for Disease Control estimated the annual average deaths attributable to excessive alcohol use to be more than 140,000 and the economic cost of AUD to be $249 billion. Current treatments for AUD include a combination of cognitive behavioral therapy, medication, and other counseling. Currently there are four FDA approved medications for treatment of AUD; disulfiram, naltrexone, extended-release naltrexone, and acamprosate. Although it appears that approximately 25% of those with AUD achieve recovery (that is, asymptomatic low risk drinking or abstinent) without treatment, those receiving any form of treatment tended to have better outcomes. Unfortunately, only 1.1 million (or 4% of the 27.6 million eligible) received any form of treatment, with 362,000 (1.3%) receiving treatment with an approved pharmacological therapeutic highlighting the need for improved access to care and more effective and better tolerated pharmacological treatments. Preclinical and available clinical data highlight the potential of selective, reversible ALDH2 inhibition as a promising validated target for treatment of AUD. Amygdala Neurosciences is developing ANS-858, a proprietary, potent, selective, and reversible inhibitor of ALDH2, for the safe treatment of AUD. Our objective is to 1) conduct a study to affirm the efficacy of ANS-858 in an animal model of AUD occurs at doses predicted to be efficacious and 2) complete the requisite IND-enabling studies with ANS-858, to enable submission of an IND for the safe treatment of patients with AUD. 1


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: 2025 ( Subtotal = $0 )
2025	2024	AMYGDALA NEUROSCIENCES, INC.	509 HALE ST	PALO ALTO	CA	94301	SANTA CLARA	USA	Alcohol Research Programs	000	2	8/25/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,055,000 )
2024	2024	AMYGDALA NEUROSCIENCES, INC.	509 HALE ST	PALO ALTO	CA	94301	SANTA CLARA	USA	Alcohol Research Programs	000	1	5/7/2024	SUPPLEMENT FOR EXPANSION	$55,000
2024	2024	AMYGDALA NEUROSCIENCES, INC.	509 HALE ST	PALO ALTO	CA	94301	SANTA CLARA	USA	Alcohol Research Programs	001	2	7/23/2024	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,055,000

Issue Date FY: 2023 ( Subtotal = $1,000,000 )
2023	2023	AMYGDALA NEUROSCIENCES, INC.	509 HALE ST	PALO ALTO	CA	94301	SANTA CLARA	USA	Alcohol Research Programs	000	1	7/31/2023	NEW	$1,000,000
2023	2023	AMYGDALA NEUROSCIENCES, INC.	509 HALE ST	PALO ALTO	CA	94301	SANTA CLARA	USA	Alcohol Research Programs	001	1	9/26/2023	NEW	$0
														Subtotal = $1,000,000

Grand Total All Awards = $2,055,000

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Investigational New Drug (IND)-enabling and Early-Stage Development of Selective, Reversible, Orally Bioavailable ALDH2 inhibitor ANS-00858 to Treat Alcohol Use Disorder.

Award Number: U43AA030689

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: 08/01/2023

PERIOD OF PERFORMANCE END DATE: 07/31/2025

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