Amygdala Neurosciences, NIAAA to Conduct ANS-6637 Study

Amygdala Neurosciences announced 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.

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