Amygdala Neurosciences Awarded $2.0 million NIH Grant to Conduct IND Enabling Studies

ANS-858, a new selective ALDH2 Inhibitor in pre-clinical development to reduce craving and relapse for patients being treated for alcohol and other substance use disorders.

SAN FRANCISCO, Aug. 1, 2023/PRNewswire/ — Amygdala Neurosciences (a private company) has been awarded a $2.0 million NIH grant to support the project titled “Investigational New Drug (IND)-enabling and Early-Stage Development of Selective, Reversible, Orally Bioavailable ALDH2 inhibitor ANS-00858 to Treat Alcohol Use Disorder.” This award is made from the National Institute on Alcohol Abuse and Alcoholism (NIAAA, an Institute of the National Institutes of Health (NIH)).

Use of alcohol and alcohol use disorder (AUD) remains high. 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. Highlighting the need for more effective and better tolerated treatments, only 362,000 (1.3%) of patients with Alcohol Use Disorder (AUD) receive treatment with a medication.

Preclinical and available clinical data demonstrate the potential of selective, reversible ALDH2 inhibition as a promising 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.

ANS-858, a new chemical entity, works in the brain’s ‘neural interface between motivation and action’ to reduce the dopamine surge responsible for craving. Inhibition of ALDH2 has been shown to reduce craving and drug seeking behavior in preclinical studies against multiple addictive agents and has the potential for use as pharmacotherapy for substance use disorders (SUD).

“We are delighted to receive this competitive award from the NIH in recognition of our innovative approach to the treatment of alcohol and other substance use disorders. This award will enable the development of ANS-858 through pre-clinical evaluation required of an investigational new drug (IND) application to the FDA.” said Brent Blackburn, PhD, Amygdala co-founder and CEO.

About ANS-858

ANS-858 is a selective and reversible aldehyde dehydrogenase 2 (ALDH2) inhibitor, a new chemical entity with a novel mechanism of action for treating SUD. Based on its mechanism of action in the brain to prevent pathophysiologic dopamine surge without changes to basal dopamine (Nature Medicine 16:1024, 2010), ANS-858 has the potential to prevent drug seeking behavior, craving and relapse. In preclinical studies, ALDH2 inhibition reduced self-administration, cue- and drug-primed relapse in multiple models of SUD and demonstrated anti-anxiety properties in models of stress. ANS-858 is currently in pre-clinical development for AUD.

About Amygdala Neurosciences Inc.

Amygdala Neurosciences is a biopharmaceutical company whose mission is to address the growing unmet need associated with alcohol use disorder (AUD) and other substance use disorders (SUD) by discovering, developing, and commercializing safe and effective pharmacotherapies to treat and prevent addiction. The company was formed based on technology discovered and developed by members of the companies’ leadership team while at CV Therapeutics and acquired from Gilead Sciences.

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The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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