Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has selected Crown CRO, based in Finland, to manage its Phase III trial for AD04 for the treatment of alcohol use disorder (AUD). The FDA approved protocol for the Phase III trial will enroll 290 patients in 30 clinical sites across Europe.

William Stilley, chief executive officer of Adial Pharmaceuticals, said, “We are excited to begin our Phase III trial of AD04 in the first half of 2019, and look forward to partnering with Crown following an extensive selection process and the completion of their feasibility studies. Partnering with Crown allows us to leverage their broad experience, as well as their understanding of local regulatory processes combined with a wide network of investigators and key opinion leaders. The strength of the Phase II results, which showed a reduction in frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance) and no overt safety concerns, allows us to keep the trial at a manageable size and should reduce the time and costs associated with Phase III clinical trials.”

Tarja Leikas, chief executive officer of Crown CRO, said, “We are honored to have been selected by Adial to help oversee this important trial. The alcohol addiction market is dramatically underserved with very limited and often ineffective options for patients.  Over 55 million people are afflicted with this disease in Europe alone.  Given the prevalence of alcohol use disorder and the targeted genotype for AD04, we expect to be able to leverage our geographic expertise, especially within Scandinavia and Eastern Europe, to rapidly enroll patients while effectively managing costs.”