Benzinga | Aug 20, 2021 10:48AM EDT

Adial Pharmaceuticals Reaches Full Enrollment Target For ONWARD Phase 3 Trial Of AD04 For Treatment Of Patients With Alcohol Use Disorder

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announces it has reached its full enrollment target of 290 subjects in the Company's ONWARD(tm) 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, stated, "Meeting our enrollment target is a major achievement in our ONWARD(tm) 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 U.S. 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(tm). 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."