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Amygdala Initiates Phase Ib Clinical Study Of ANS-6637, The First-In-Class Selective ALDH2 Inhibitor In Development As A Treatment For Substance Use Disorder

8/1/2017 9:33:59 AM

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PALO ALTO, Calif., Aug. 1, 2017 /PRNewswire/ -- Amygdala Neurosciences Inc., a biopharmaceutical company focused on the development and commercialization of first-in-class drug candidates for addiction disorders, initiated a Phase 1b clinical study to assess the safety and tolerability of co-administration of ANS-6637 and alcohol. ANS-6637 is a highly selective ALDH2 inhibitor that prevents abnormal dopamine surges in the brain that drive craving, addiction and relapse.

"Starting this clinical study is an important development milestone for ANS-6637 and operational proof point for Amygdala," said Peter Strumph, Amygdala co-founder and CEO. "In less than 6 months since acquiring the ANS-6637 asset from Gilead Sciences, we submitted the IND, FDA has reviewed our development plans and cleared us to proceed, ANS-6637 is back in the clinic and we are creating value with human clinical data."

"Results of this ongoing Phase 1b clinical study will identify the specific dose response and tolerability of co-administration of ANS-6637 with alcohol. This will enable parallel development for alcohol, cocaine and opioid addiction disorders," commented Ivan Diamond, MD, PhD, Amygdala co-founder and Chief Scientific Officer.

Clinical Study Design

ANS-A-C1-001 is a 48 subject, Phase 1b, dose-ranging study to evaluate the safety and tolerability of the co-administration of ANS-6637 and alcohol in healthy male moderate drinkers. In this single-center, randomized, double-blind, placebo-controlled, ascending dose study, up to 6 dose levels of ANS-6637 (25, 50, 100, 200, 400, 600 mg) will be studied in combination with a multiple-drink alcohol challenge.

About ANS-6637

ANS-6637 utilizes a novel pathway for the treatment of addiction. ANS-6637 is a highly selective ALDH2 inhibitor that modifies dopaminergic tone in the brain by preventing abnormal dopamine surges that drive craving without changing basal dopamine levels.  In published preclinical studies, ANS-6637 reduced cocaine, alcohol and opioid craving and relapse. This profile, which prevents drug-seeking behavior, has the potential to treat drug addictions and prevent relapse. Prior Phase 1 clinical trials of ANS-6637 in 99 human subjects demonstrated a pharmacokinetic and safety profile that support continued development.

About Addiction and Substance Abuse

The 2016 Surgeon General's report classifies addiction and substance misuse as a "National Public Health Crisis." In the US in 2015, 90 people died from opioid overdose each day, 67,000 deaths were due to drug overdose, 88,000 deaths were alcohol related, and 22 million people were addicted to alcohol or other drugs. The abuse of alcohol, tobacco, and illicit drugs costs more than $700 billion annually for related crime, lost work productivity, and health care. $33 billion is spent each year to treat substance abuse, but only 11% of those who need treatment are treated and with less than 4% of that treatment spending for pharmacotherapy, there is a clear unmet need for better treatments and for greater treatment utilization and a large opportunity for safe and effective pharmacotherapy to treat substance abuse and addiction.

About Amygdala Neurosciences Inc.

Amygdala Neurosciences is a biopharmaceutical company focused on the development and commercialization of first-in-class drug candidates for the treatment of addiction 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; and Chief Financial Officer Adrienne MacMillan.

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