Cooperative Agreement U43AA030689
- This $673,500 Project Grant from the National Institutes of Health's National Institute on Alcohol Abuse and Alcoholism will fund Amygdala Neurosciences, Inc. to develop new, potent, selective, and reversible inhibitors of aldehyde dehydrogenase 2 (ALDH2) for the treatment of alcohol use disorder. The goal is to implement an innovative screening technology to discover novel compounds that reduce craving and alcohol consumption by selectively inhibiting ALDH2 in a reversible manner, avoiding...
- The National Institute on Alcohol Abuse and Alcoholism (NIAAA), under the Alcohol Research Programs (CFDA 93.273), awarded a $999,393 Cooperative Agreement to Stress Therapeutics, Inc., a California-based pharmaceutical company, to conduct Investigational New Drug (IND)-enabling studies for a novel therapeutic to treat Alcohol Use Disorder (AUD). The key products and services to be delivered include: 1) Manufacture and validation of the test article for IND-enabling studies; 2) Development and...
- This federal Cooperative Agreement award of $1,001,425.00 from the National Institute on Alcohol Abuse and Alcoholism (NIAAA), under the Alcohol Research Programs (CFDA 93.273) federal grant program, aims to develop a novel and functionally selective 5-HT2C receptor agonist for treating Alcohol Use Disorder (AUD). The project's goal is to confirm and extend the drug candidacy of KB128, a proprietary compound developed by Kuleon LLC, as a potential therapeutic medication for AUD. The award will...
- The National Institute on Alcohol Abuse and Alcoholism (NIAAA), under the Alcohol Research Programs (CFDA 93.273), awarded a $901,666 Project Grant to Research Triangle Institute (RTI International) to develop small molecule modulators of the RXFP3 receptor as potential therapeutic agents for alcohol use disorder (AUD). The project aims to further optimize and evaluate the effectiveness of the RXFP3 negative allosteric modulators (NAMs) RLX-33 and RLX-79 in animal models of alcohol...
- The National Institute on Alcohol Abuse and Alcoholism (NIAAA), under the Alcohol Research Programs (CFDA 93.273), awarded a $390,454 Project Grant to Envisbio LLC to develop novel therapeutic aptamers targeting phosphodiesterase 4B (PDE4B) for the treatment of alcohol use disorder (AUD). The project aims to identify and characterize PDE4B-specific aptamers that can modulate PDE4B activity, with the goal of advancing these modulators into in vivo testing and eventual human clinical trials for...
- Under a $368,673 Project Grant from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) awarded on September 25, 2023, Artiam Bio Inc., a minority-owned small disadvantaged biotechnology company, is developing and evaluating second-generation partial inverse agonists targeting the type 1 cannabinoid (CB1) receptor as a potential therapy for alcohol use disorder (AUD). Artiam Bio is conducting preclinical efficacy studies of its lead CB1 receptor partial inverse agonist compound in rat...
- The National Institute on Alcohol Abuse and Alcoholism (NIAAA) awarded a $498,002 Project Grant under the Alcohol Research Programs (CFDA 93.273) to the University of Illinois to conduct a study aimed at increasing alcohol abstinence in young adults with alcohol use disorder (AUD). The overall goals of this 3-year project are to: (1) test the efficacy of combining contingency management (CM) with problem-solving therapy (CM-PST) versus CM alone in a 2-arm pilot randomized controlled trial, and...
- This Project Grant award was provided by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), which falls under the federal Alcohol Research Programs (CFDA 93.273). The $692,723 award will support a double-blind, placebo-controlled clinical trial to test whether the drug suvorexant can be used as a novel therapeutic for alcohol use disorder (AUD) and stress-related drinking. The 5-year project, running from September 2025 through August 2030, will be conducted by researchers at The...
- This federal Project Grant award of $423,313, provided by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) under the Alcohol Research Programs (CFDA 93.273), aims to develop an AI-driven platform for identifying potential therapeutic candidates for Alcohol Use Disorder (AUD). The award to Biosymetrics Inc., based in Huntington, NY, will leverage the company's existing AI-based zebrafish behavioral screening technology and AUD-specific experimental findings to create a commercial...
- This $856,625 Project Grant award from the National Institute on Alcohol Abuse and Alcoholism (NIAAA), under the Alcohol Research Programs (CFDA 93.273), supports an exploratory randomized controlled trial (RCT) of the effects of oral semaglutide on alcohol craving and consumption. The University of Colorado-Denver, as the prime awardee, will conduct this 2-year study to assess the safety, tolerability, and efficacy of semaglutide, a glucagon-like peptide-1 (GLP-1) agonist, compared to placebo...
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
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | $0 | 8/25/25 | ||
| Not listed | $1.0m | 7/23/24 | ||
| Not listed | $55.0k | 5/7/24 | ||
| Not listed | $55.0k | 5/7/24 | ||
| Not listed | $0 | 9/26/23 |