Amygdala Neurosciences Announces the $12.4 Million HEAL Initiative Sponsored SEARCH (Safety and Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People with Opioid Use Disorder) Program of Phase 2 Clinical Studies

Wednesday, September 19, 2018 Clinical Trials News
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- ANS-6637 is a new chemical entity (a selective ALDH2 Inhibitor) with a mechanism of action that may prevent craving and relapse for patients being treated for substance use disorders

SAN FRANCISCO, Sept. 19, 2018 /PRNewswire/ -- Amygdala Neurosciences (a private company) announced today the SEARCH program

of Phase 2 clinical studies which are sponsored by the National Institute of Allergy and Infectious Diseases (NIAID, a division of NIH) and are being conducted by the NIH Clinical Center and the Institute of Human Virology (IHV) at the University of Maryland School of Medicine. The project is led by Dr. Henry Masur, Chief of the NIH Critical Care Medicine Department and Dr. Shyam Kottilil, Professor of Medicine, Director Division of Clinical Care & Research, Institute of Human Virology, University of Maryland School of Medicine. The SEARCH program of clinical studies will receive up to $12.4 million of funding from the NIH HEAL (Helping to End Addiction Long-term) initiative. The SEARCH program of Phase 2 clinical studies will test the safety, efficacy, and underlying mechanisms of craving reduction as a strategy to prevent opioid misuse, dependence, and relapse, and improve the morbidity and reduce mortality in people with opioid use disorder.

ANS-6637 has been studied in 135 human subjects. It is a selective ALDH2 Inhibitor that reduces dopamine surge associated with craving without affecting basal dopamine. ANS-6637 reduced craving and drug seeking behavior in preclinical studies and has the potential to be used as pharmacotherapy for any substance and behavior-based addiction.

In 2015, the opioid crisis cost the $504 Billion, or 2.8% of US GDP. In 2016, 1.7 million Americans had a prescription opioid use disorder. In 2017, there were nearly 50,000 opioid related deaths, or 134 deaths every day from opioid overdose – more than peak HIV deaths.

"Patients being treated for opioid use disorder report craving as one of the more persistent symptoms and craving often leads to relapse. The mechanism of action of ANS-6637, which prevents craving and relapse in preclinical studies, may prove to be a useful treatment for opioid use disorder," said Ivan Diamond MD, PhD, Amygdala co-founder and Chief Scientific Officer.

About the NIH HEAL InitiativeThe HEAL (Helping to End Addiction Long-term) initiative is an ambitious, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.

About ANS-6637ANS-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 anxiolytic properties in models of stress. Amygdala acquired the asset ANS-6637 from Gilead Sciences in 2017. ANS-6637 has completed extensive Phase 1 studies in 135 human subjects and is ready for outpatient Phase 2 efficacy studies.

About Addiction and Substance Abuse in the United StatesThe 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 is a biopharmaceutical company focused on developing and commercializing first-in-class therapy for substance use disorders. Early stage development programs include opioid use disorder, alcohol use disorder, cocaine use disorder and smoking cessation. 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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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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