ADial Pharmaceuticals Announces Publication of Study on AD04 for the Treatment of Patients With Alcohol Use Disorder

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| Source: ADial Pharmaceuticals, LLC

CHARLOTTESVILLE, Va., Aug. 12, 2013 (GLOBE NEWSWIRE) -- ADial Pharmaceuticals (ADial) announced today that the prestigious American Journal of Psychiatry ("AJP") has published a seminal article on the treatment of alcohol addiction using ADial's drug, AD04, in patients with selected genotypes. The study is a major step toward developing a more personalized and effective approach to the treatment of alcohol use disorder based on a patient's genetic makeup. The article is currently available through the online journal AJP in Advance.

Professor Bankole A. Johnson, the scientific founder and Chairman of ADial, and his team at the University of Virginia have previously shown that variations in genes that encode the serotonin transporter, a protein which regulates the concentration of serotonin between nerve cells, can significantly impact drinking intensity, as measured in number of drinks per drinking day, percentage of days abstinent, and percentage of heavy drinking days. The authors previously reported that two genotype combinations in the serotonin transporter gene predicted a significant reduction in the severity of alcohol consumption among patients receiving AD04. In this publication, they reported that polymorphisms in the HTR3A and HTR3B genes, which directly regulate the functioning of 5-HT3 receptors and their binding to AD04, are also predictive of a positive response to AD04. This paper provides the evidence for the panel of genotypes used to select patients for treatment with AD04.

"The ability of AD04 to reduce heavy drinking is a breakthrough for millions of people who are struggling to manage their alcohol use, but are either unable or unwilling to tolerate the treatments available today," said William Stilley, CEO of ADial. "By helping them drink at safer levels, AD04 brings hope to millions in the Unites States and the world suffering from the terrible affliction of alcohol addiction. With Phase III trials expected to begin in the next few months, we hope to launch the product commercially in 2017."

About AD04

AD04 is being developed as a treatment for alcohol use disorder in patients of select genotypes. AD04 is a serotonin-3 (5HT3) antagonist that is believed to interrupt the reinforcing effects of alcohol, and thus reduces the urge to drink. Such reinforcing effects are thought to be exaggerated in patients that have certain mutations of the genes that control serotonin function in the brain, and these are the patients targeted for treatment with AD04. AD04 contains an ultra-low dose of the active ingredient ondansetron, which is currently marketed as an anti-emetic for post-operative and post-chemotherapy nausea. Doses effective for treating alcohol addiction are well below those used to treat emesis. Clinical and non-clinical experience to date suggest that higher doses like those used for the treatment of emesis may have reduced efficacy for treating addiction and additional safety risks associated with their chronic use as would be required for treatment of addiction.

About ADial Pharmaceuticals, LLC

ADial Pharmaceuticals is a privately held pharmaceutical company developing medications for treating addiction diseases and disorders, including alcohol and drug addictions (cocaine, opioids, methamphetamines), as well as other addiction-like behaviors such as those related to obesity and eating disorders. The company's most advanced compound, AD04, specifically targets alcohol use disorder (previously called alcohol abuse and dependence) in patients with selected genotypes. For more information about ADial Pharmaceuticals, please visit http://www.adialpharma.com.  

An online version of the AJP in Advance article can be found at:

http://ajp.psychiatryonline.org/Article.aspx?ArticleID=1722045

William Stilley, CEO
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