CHARLOTTESVILLE, VA / ACCESSWIRE / June 25, 2020 / ADial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) (“Adial”), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has commenced its landmark ONWARD™ pivotal Phase 3 clinical trial in Poland to investigate its lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes.
“We are pleased to announce we were able to begin the trial less than two weeks after we received approval from Saudi Arabia Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the relevant regional Polish ethics committees overseeing the trial,” commented William Stilley, Chief Executive Officer of Adial Pharmaceuticals. “It is a particular honor to have the clinical group led by Dr. Dariusz Malicki at the prestigious Centrum Medyczne Luxmed in Lublin, Poland as part of the ONWARD™ team. We are excited to have initiated trial recruitment in Poland and expect the majority of the ONWARD™ trial sites to be fully operational this summer.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns (there were no statistically significant serious adverse events reported). AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. www.adialpharma.com
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