Amygdala Neurosciences Awarded $1.35 million NIH Grant to Conduct Long Term, Phase 3 Enabling, Toxicology Studies


SAN FRANCISCO, Oct. 21, 2019 /PRNewswire/ -- Amygdala Neurosciences (a private company) has been awarded up to $1.35 million NIH grant support for the project titled "26- & 39-Week Toxicity Studies of ANS-6637 in Rats and Monkeys (respectively) to Enable 6+ Months Dosing in Alcohol (and other Substance) Use Disorder Phase 3 Studies." This award is made from the National Institute on Alcohol Abuse and Alcoholism (NIAAA, an Institute of the National Institutes of Health (NIH)) under award number U01AA028003.

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.

ANS-6637 is currently in Phase 2 clinical development for alcohol use disorder with plans to start additional Phase 2 studies in opioid use disorder and smoking cessation. Current toxicology studies support 3-months duration human dosing. The long-term toxicology studies supported by this grant will enable Phase 3 clinical trials with 6+ months dosing.

"This competitive award from NIH will help Amygdala develop ANS-6637 as a treatment for substance use disorder," said Peter Strumph, Amygdala co-founder and CEO. "These long duration non-clinical studies will now be off the critical path for starting Phase 3 clinical development."

About ANS-6637

ANS-6637 is a selective and reversible aldehyde dehydrogenase 2 (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 Amygdala Neurosciences, Inc.

Amygdala is a biopharmaceutical company focused on addressing the large and growing unmet need associated with substance use disorders. Development programs include treatment of opioid, nicotine, alcohol and cocaine use disorders.

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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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SOURCE Amygdala Neurosciences


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