Adial Pharmaceuticals Reaches Full Enrollment Target for ONWARD Phase 3 Trial of AD04 for the Treatment of Patients With Alcohol Use Disorder

Adial Pharmaceuticals, Inc. recently announced it has reached its full enrollment target of 290 subjects in the company’s ONWARD Phase 3 trial evaluating AD04 as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes. ONWARD trial completion is expected in the first quarter of 2022.

William Stilley, Adial’s Chief Executive Officer, said “Meeting our enrollment target is a major achievement in our ONWARD Phase 3 trial. I would like to thank all of the investigators involved in the trial that helped us reach this important milestone in spite of the ongoing pandemic. Trial engagement interest among patients continues to be strong, and consistent with what was seen in previous clinical testing; approximately 33% of those patients screened tested positive for the genetics expected to indicate responsiveness to AD04. Our confidence in the market potential of AD04 is bolstered by this apparent confirmation of the percentage of the population with the target genetics. We estimate the market potential for AD04 to be in excess of $36 billion in the US alone, and we are evaluating marketing and distribution channel partners in the United States and abroad.”

Mr. Stilley continued “Due to increased demand for entry into the study near the end of our trial recruitment period, we still have additional patients that have been genetically screened as positive for enrollment in the study but have not yet been enrolled in ONWARD. With this opportunity to rapidly enroll additional patients to increase the statistical power of the trial, and, we have determined to enroll these additional, already screened patients through the end of this month. This means total trial enrollment will exceed our enrollment goal of 290 patients. We are also encouraged by the high study retention rate with more patients than expected continuing to engage in the trial following enrollment. Moreover, no serious adverse events have been reported to date that have been determined to be study drug related, and the vast majority of adverse events have been mild and also unrelated. The retention rate and safety data are supportive of a well-tolerated therapy, differentiating AD04 from other marketed AUD therapies.”

The ONWARD trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes. Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled. The primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period. ONWARD is currently being conducted in 25 clinical sites in seven countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Estonia, Bulgaria, and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Ccompany’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. The company is also developing adenosine analogs for the treatment of pain and other disorders. For more information, visit www.adialpharma.com.