Adial Pharmaceuticals and Crown CRO announced Crown’s engagement to manage Adial’s Phase 3 clinical trial for AD04 for the treatment of alcohol use disorder (AUD). The FDA approved protocol for this Phase 3 clinical trial is a 24-week trial with 290 patients in 30 clinical sites in 5 European countries.
“We are excited to begin our Phase 3 clinical 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,” William Stilley, CEO of Adial Pharmaceuticals, said. “The strength of the Phase 2 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 3 clinical trials.”
“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,” Tarja Leikas, Chief Executive Officer of Crown CRO, said. “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.”