CHARLOTTESVILLE, Va., April 30, 2014 (GLOBE NEWSWIRE) -- ADial Pharmaceuticals, LLC (ADial), announced today the issuance of U.S. Patent No. 8,697,361 which covers the use of a serotonin-3 (5-HT3) antagonist for the treatment of alcohol related diseases, including Alcohol Use Disorder (AUD), in patients having the LL/TT genotype of the serotonin transporter gene. This patent will provide protection through at least April 28, 2030.
The patent also specifically covers treatment of patients having the LL/TT genotype using ADial's lead product AD04, a 5-HT3 antagonist. AD04 interrupts the reinforcing effects of alcohol, thereby reducing the urge to drink. Such reinforcing effects are thought to be exaggerated in patients that have certain mutations of the genes (LL/TT) that control serotonin function in the brain. Unlike currently available solutions in the U.S., AD04 does not require abstinence but allows patients to better control drinking and reduce heavy drinking.
"The issuance of this patent further reinforces ADial's position as a leader in the field of alcohol addiction and personalized medicine," said William Stilley, CEO. "With the intellectual property protection afforded by this patent, we have a solid business case to develop AD04 for the treatment of Alcohol Use Disorder. ADial also has additional patents pending that should extend the patent life of AD04 even further and that offer the possibility of product line extensions into other addictive disease states."
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. For more information about ADial Pharmaceuticals, please visit http://www.adialpharma.com.
About AD04
ADial's lead product, AD04, is a serotonin-3 (5-HT3) antagonist targeted for treating alcohol use disorder (AUD) in patients having certain genetic markers related to the serotonin system. AD04 demonstrated efficacy at reducing both the frequency and quantity of drinking in a 283-patient Phase IIb study and is preparing to commence pivotal Phase III trials for treating AUD in genetic marker positive patients. AD04 is also hypothesized as a potential treatment for other addiction diseases such as obesity, illegal drug use, and smoking. The active ingredient in AD04 is ondansetron, which is currently approved 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 may also entail additional safety risks associated with chronic administration as would be required for treatment of addiction.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding: the company's patents, patent term extension and intellectual property protection, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.