Adial Pharmaceuticals Receives Approval to Commence Phase 3 Trial in Bulgaria

CHARLOTTESVILLE, VA / ACCESSWIRE / February 19, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received approval to commence its Phase 3 study to investigate AD04 as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in Bulgaria in persons with certain target genotypes related to the serotonin transporter and receptor genes. This includes receiving approvals from both the Bulgarian Drug Agency and the Bulgarian Ethics Committee for Clinical Trials overseeing the study.

“Bulgaria is expected be an important country in our Phase 3 trial of AD04 in biomarker-positive study participants,” stated William Stilley, Chief Executive Officer of Adial Pharmaceuticals. “Approximately one-half of our planned clinical sites are located in Finland and Bulgaria, and we have already opened the trial in Finland. The approval to commence the Phase 3 trial in Bulgaria was received ahead of schedule, which we anticipate will accelerate enrollment and reduce the cost of the trial.”

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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a 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