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

> **NIH NIH U43** · AMYGDALA NEUROSCIENCES, INC. · 2023 · $1,000,000

## Abstract

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

## Key facts

- **NIH application ID:** 10748087
- **Project number:** 1U43AA030689-01A1
- **Recipient organization:** AMYGDALA NEUROSCIENCES, INC.
- **Principal Investigator:** Brent Keith Blackburn
- **Activity code:** U43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,000,000
- **Award type:** 1
- **Project period:** 2023-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10748087

## Citation

> US National Institutes of Health, RePORTER application 10748087, Investigational New Drug (IND)-enabling and Early-Stage Development of Selective, Reversible, Orally Bioavailable ALDH2 inhibitor ANS-00858 to Treat Alcohol Use Disorder. (1U43AA030689-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10748087. Licensed CC0.

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