Adial Pharmaceuticals Engages CRO to Begin Phase 3 Clinical Trials

Adial Pharmaceuticals, Inc. and Crown CRO recently 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.

William Stilley, CEO of Adial Pharmaceuticals, said “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. 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.”

Tarja Leikas, Chief Executive Officer of Crown CRO, added “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.”

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The company’s lead investigational new drug candidate, AD04, is a genetically targeted therapeutic agent for the treatment of alcohol use disorder (AUD). 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). The company plans to commence a Phase 3 clinical trial using AD04 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. AD04 is also believed to have the potential to treat other addictive disorders, such as opioid use disorder, gambling, and obesity.

Crown CRO is a privately owned Finnish contract research organization founded in 2005. Our headquarters is in Espoo, which is located in Finland’s capital city region. Crown CRO provides full service clinical operations or any services related to clinical operations. Crown CRO provides services in the pharmaceutical, biotechnology, functional food and medical device sectors, as well as to other contract research organizations. Our services also cover quality assurance, pharmacovigilance, regulatory, and translation services. We have been involved in over 900 clinical studies in more than 18 countries in various therapeutic areas and in all phases of clinical development. We currently have 100 active clinical trials ongoing. Our vast experience enables us to serve our customers in coordinating trials from early phases up to late-phase and real-world studies with high quality data and on time delivery within budget.