Amygdala Neurosciences Announces Dosing of the First Patient in the NIH Funded Phase 2 Proof-Of-Concept study of ANS-6637 for the Treatment of Alcohol Use Disorder

ANS-6637 is a new chemical entity selective ALDH2 Inhibitor with a mechanism of action expected to prevent craving and relapse for patients being treated for substance use disorders including alcohol use disorder.

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Amygdala Neurosciences Inc.

Oct 17, 2019, 08:37 ET

SAN FRANCISCO, Oct. 17, 2019 /PRNewswire/ -- Amygdala Neurosciences (a private company) announced today the start of dosing in the National Institute on Alcohol Abuse and Alcoholism (NIAAA, an Institute of the National Institutes of Health (NIH)) sponsored Phase 2 proof-of-concept study of ANS-6637 in patients with alcohol use disorder. In the United States, every year 88,000 people die from alcohol-related causes, there are 17 million people with alcohol use disorder, and annual costs associated with alcohol use disorder exceed $250 billion.

ANS-6637 has an anti-craving mechanism of action working in the brain's nucleus accumbens to reduce the dopamine surge responsible for craving. ANS-6637 has been shown to reduce craving and drug seeking behavior in preclinical studies against multiple addictive agonists and has the potential for use as pharmacotherapy for substance and behavior-based addictions.

"Today we achieved the important milestone, enrolling a patient into our first Phase 2 clinical trial," said Peter Strumph, Amygdala co-founder and CEO. "In addition, we plan to initiate several other Phase 2 proof-of-concept studies early next year including an NIH HEAL Initiative funded Phase 2 study of ANS-6637 in patients with opioid use disorder and a Phase 2 study of ANS-6637 as an aide to smoking cessation."

About ANS-6637

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 preclinical studies, ALDH2 inhibition reduced self-administration, cue- and drug-primed relapse in nicotine, alcohol, cocaine, heroin, methamphetamine and binge eating models and also demonstrated anti-anxiety properties in models of stress. Amygdala acquired the asset ANS-6637 as a spin-out from Gilead Sciences. ANS-6637 has completed extensive Phase 1 studies in 150 human subjects and is currently in Phase 2 clinical development.

About the Clinical Study

This study is a 3-arm, double-blind, randomized, placebo-controlled, parallel group, 3-site study designed to assess the effects of ANS-6637 as compared with placebo on responses to in vivo alcohol cue exposure in the human laboratory setting. The study will enroll 81 treatment seeking patients who meet DSM-5 criteria for at least moderate alcohol use disorder. Endpoints include laboratory paradigm alcohol cue-elicited alcohol craving, percentage of subjects with no heavy drinking days, percentage of subjects abstinent from alcohol, and safety. Additional details about the study, "Human Laboratory Study of ANS-6637 for Alcohol Use Disorder," are available on clinicaltrials.gov using the identifier NCT03970109.

About Amygdala Neurosciences, Inc.

Amygdala is a biopharmaceutical company focused on improving public health by developing and commercializing first-in-class therapy to treat substance use disorders. Development programs include treatment and prevention of opioid, nicotine, alcohol and cocaine use disorders. 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.

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