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

NIH RePORTER · NIH · U43 · $55,000 · view on reporter.nih.gov ↗

Abstract

Project Summary 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 ANS-858, a selective, reversible ALDH2 inhibition as a promising treatment of AUD. The I-CORPS® Program will aid our team in gaining a deeper understanding of the potential role of ANS-858 in the treatment of patients with AUD alone or in combination with existing therapeutic agents. Furthermore, the potential overlap of emerging psychosocial therapies and mobile apps on the treatment of AUD with ANS-858 remain to be explored. Finally, although we anticipate adopting a public and private model for reimbursement, the team is anticipating gaining new knowledge and information about reimbursement to maximize commercialization.

Key facts

NIH application ID
11019510
Project number
3U43AA030689-01A1S1
Recipient
AMYGDALA NEUROSCIENCES, INC.
Principal Investigator
Brent Keith Blackburn
Activity code
U43
Funding institute
NIH
Fiscal year
2024
Award amount
$55,000
Award type
3
Project period
2023-08-01 → 2025-07-31