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