Notice of Intent to Publish a Funding Opportunity Announcement for Medications Development for the Treatment of Alcohol Use Disorder (AUD) or Alcohol-Related Organ Damage (AROD), or the Combination of AUD and AROD (U01 Clinical Trial Optional)

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Notice Number: NOT-AA-19-032

Key Dates

Release Date: November 08, 2019
Estimated Publication Date of Funding Opportunity Announcement: January 15, 2020
First Estimated Application Due Date: April 01, 2020
Earliest Estimated Award Date: September 01, 2020
Earliest Estimated Start Date: September 01, 2020

Related Announcements
None

Issued by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

The National Institute on Alcohol Abuse and Alcoholism intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research that advances promising compounds through the drug development pipeline for the treatment of Alcohol Use Disorder (AUD) or Alcohol-Related Organ Damage (AROD), or the combination of AUD and AROD. The aim of this FOA is to move candidate compounds through any single phase, or multiple phases of the development spectrum. For compounds focused on treating AUD or the combination of AUD and AROD, projects may start with lead optimization (late discovery) and go through Phase 2 proof-of-concept studies. For AROD, studies may start with lead optimization, but only go as far as Phase 1 safety tolerability trials.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in winter 2020 with an expected application due date in spring 2020.

This FOA will utilize the cooperative agreement U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into this area of biomedical science and medications development for alcohol use disorder and alcohol related organ pathology to begin to consider applying for this new FOA.

In addition, collaborative investigations combining expertise in Alcohol and Substance Use Disorders with Pathology, Pharmacology, and Toxicology will be encouraged and these investigators should also begin considering applying for this application.

Among the areas of emphasis encouraged in this initiative are the development and advancement of effective therapies for the prevention and treatment of alcohol use disorder and alcohol-related organ diseases.

The purpose of this FOA is to accelerate the pace of medications development by focusing on moving candidate compounds through the drug development pipeline. This will be accomplished by using a cooperative agreement between NIAAA and outside entities to include both profit and non-profit organizations.

Stages of Medication Development

AUD and AUD/AROD:

For medications that treat AUD, or AUD and AROD, applications can focus at any point along the drug development pipeline from lead optimization through Phase 2,This includes: lead optimization (late discovery); pre-clinical investigational new drug (IND)-enabling studies (e.g., clinical toxicology; Good Manufacturing Practice (GMP) manufacturing; and pharmacokinetics; animal efficacy studies as long as candidate compound is patentable and has a plausible path to commercialization); Phase 1 human studies (e.g., safety, tolerability, dosing, alcohol interaction); Phase 2 studies (.e., proof-of-concept human laboratory and clinical trials).

AROD:

For AROD, applications can focus at any point along the drug development pipeline from lead optimization through Phase 1. Phase 2 studies will not be considered.

The defined entry and exit points along the drug development pipeline will depend on the developmental status of the candidate compound. For example, some candidate compounds may only need one or a few IND-enabling studies, while other compounds may need an entire pre-IND package. The development stage of other compounds may require completing the IND package, securing an IND and conducting a Phase 1 human safety tolerability study. Still other compounds, focused on treating AUD or both AUD and AROD, may have completed the Phase 1 study and be ready to begin a Phase 2 proof-of-concept trial.

Candidate compounds may be either a new chemical entity or a repurposed drug that has been that has been reformulated and is eligible for FDA approval. All IND-enabling and Phase 1 studies should be conducted consistent with FDA guidelines (https://www.fda.gov/downloads/drugs/guidances/ucm073246.pdf). Proposed Phase 2 studies should consider FDA guidance https://www.fda.gov/files/drugs/published/Alcoholism---Developing-Drugs-for-Treatment.pdf .

More details will be provided in the soon to be published RFA.

HIV/AIDS related research applications will not be considered in response to the future RFA.

Funding Information

Estimated Total Funding $5.0M
Expected Number of Awards 1-4 awards
Estimated Award Ceiling For AUD treatment candidate compounds and combination AUD and AROD Phase 2 candidate compounds, budgets must not exceed $1.0 M direct costs per year. For Alcohol-related organ damage (AROD) treatment candidate compounds and combination AUD and AROD candidate compounds from lead optimization through Phase 1 , budgets must not exceed $1.0 M direct costs per year for IND enabling studies and $500,000 direct cost per year for clinical Phase 1.
Primary CFDA Numbers 93.273

Anticipated Eligible Organizations

Inquiries

Please direct all inquiries to:

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Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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