Amygdala Neurosciences and NIAAA will Conduct a Phase 2 Clinical study of ANS-6637 for the Treatment of Alcohol Use Disorder

SAN FRANCISCO, /PRNewswire/ -- Amygdala Neurosciences (a private company) announced today that the National Institute on Alcohol Abuse and Alcoholism (NIAAA, a division of NIH) will fund and conduct a Phase 2, human laboratory study of ANS-6637 for the treatment of alcohol use disorder. The randomized, double-blind, placebo-controlled Phase 2 study will assess outpatient alcohol consumption and in-clinic lab measurements of alcohol craving.

ANS-6637 is a selective ALDH2 Inhibitor that prevents pathophysiologic dopamine surge and associated craving without changes to basal dopamine. This profile, which prevents craving and drug seeking behavior, has the potential to be used as pharmacotherapy for any substance and behavior-based addiction.

In the United States, there are 17 million people with alcohol use disorder (AUD). Every year 88,000 people die from alcohol-related causes, but the effects of AUD extend much farther as AUD also effects co-workers and family. In the United States, more than 10% of children live with an adult with AUD.

"ALDH2 inhibition delivered though daidzin root extract has been an herbal remedy for alcoholism for a thousand years. ANS-6637 is a highly selective ALDH2 inhibitor which has shown efficacy in pre-clinical models of alcohol consumption and relapse. ANS-6637 has been studied in several clinical studies in 135 human subjects. In a Phase 1b human clinical study, ANS-6637 was well tolerated when administered with 5 drinks of alcohol," said Ivan Diamond MD, PhD, Amygdala co-founder and Chief Scientific Officer.

"This non-dilutive, NIAAA funded Phase 2, human laboratory, proof of concept study occupies an important place in our ANS-6637 multi-indication clinical development program. This study will be executed at leading academic sites and is designed to assess ANS-6637 as a potential treatment for alcohol use disorder with respect to craving and drinking behavior," said Peter Strumph, Amygdala co-founder and CEO.

About ANS-6637
ANS-6637 is being developed for opioid use disorder, alcohol use disorder, cocaine use disorder and smoking cessation. ANS-6637 is a selective and reversible ALDH2 inhibitor, a new chemical entity with a novel mechanism of action for treating substance use disorder. 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-6637 has the potential to prevent drug seeking behavior, craving and relapse. In pre-clinical studies, ALDH2 inhibition reduced self-administration, cue- and drug-primed relapse in nicotine, alcohol, cocaine, heroin, methamphetamine and binge eating models and also demonstrated anxiolytic properties in models of stress. Amygdala acquired the asset ANS-6637 from Gilead Sciences in 2017. ANS-6637 has completed extensive pre-clinical animal studies and Phase 1 studies.

About Addiction and Substance Abuse in the United States
The 2016 Surgeon General's report classifies addiction and substance misuse as a "national public health crisis." 22 million people (1.5 times the number of people with cancer) have a substance use disorder, but only 11% receive treatment. The abuse of alcohol, tobacco, and illicit drugs costs more than $700 billion annually for related crime, lost work productivity, and health care. A total of $33 billion is spent each year to treat substance abuse, with less than 4% of treatment spending for pharmacotherapy. There is a large unmet need for better treatments and for greater treatment utilization.

About Amygdala Neurosciences, Inc.
Amygdala Neurosciences is a biopharmaceutical company focused on developing and commercializing first-in-class therapy for substance use disorders. Early stage development programs include smoking cessation, opioid use disorder, alcohol use disorder and cocaine use disorder. Amygdala was founded and is led by industry leaders and therapeutic experts who include: Executive Chairman Lou Lange, MD, PhD; Chief Scientific Officer Ivan Diamond, MD, PhD; President and Chief Executive Officer Peter Strumph; Chief Development Officer Brent Blackburn, PhD; and Chief Financial Officer Adrienne MacMillan.

For further Information, visit www.amygns.com or contact mailroom@amygns.com

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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SOURCE Amygdala Neurosciences