# Development of novel pharmacotherapies for AUD

> **NIH NIH R41** · NEUROEPIGENIX, LLC · 2022 · $392,942

## Abstract

Project Summary
The overall goal of this proposal is to characterize a lead compound with a novel mode of action (MOA) that
reduces both stress- and dependence-related alcohol drinking in a preclinical model of Alcohol Use Disorder
(AUD). AUD is a major problem in the U.S. as approximately 13.9% of adults meet AUD criteria per year. The
annual economic burden of AUD is estimated at >$200 billion and AUD is a leading cause of preventable deaths
in the USA. Persistent alcohol abuse and dependence is difficult to treat in part because alcohol increases the
reactivity of the body’s stress systems. The influence of stress systems facilitates the “the dark side of addiction”,
and stress is a primary factor that triggers relapse. Therefore, pharmacotherapies that can reduce stress- and
dependence-associated alcohol drinking could reduce both heavy drinking and stress-triggered relapse in
individuals suffering from AUD. We recently discovered that systemic administration of an epigenetic enzyme
inhibitor reduced both stress- and dependence-potentiated alcohol drinking in a preclinical model. We have filed
for patent protection of this entirely novel MOA to treat AUD, which provides a commercial path forward. In this
Phase I STTR application, we will evaluate oral bioavailability of our lead compound to examine whether the
preferred oral method of delivery is feasible for AUD treatment. We will also examine maximum tolerated dose
(MTD) and behavioral toxicity measures. We will then determine optimal dosing conditions, and we seek to
establish strong proof-of-principle data that these compounds reduce dependence- and stress-related alcohol
drinking in multiple preclinical models and multiple mouse strains in both male and female mice. At the conclusion
of these aims, we expect to have sufficient pre-clinical information for subsequent Phase II STTR studies
targeting a future Investigational New Drug (IND) application.

## Key facts

- **NIH application ID:** 10382131
- **Project number:** 1R41AA029365-01A1
- **Recipient organization:** NEUROEPIGENIX, LLC
- **Principal Investigator:** Ethan Michael Anderson
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $392,942
- **Award type:** 1
- **Project period:** 2022-03-01 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10382131

## Citation

> US National Institutes of Health, RePORTER application 10382131, Development of novel pharmacotherapies for AUD (1R41AA029365-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10382131. Licensed CC0.

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