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Adial Pharmaceuticals Exceeds Enrollment Target in ONWARD™ Phase 3 Trial of AD04 for the Treatment of Patients with Alcohol Use Disorder

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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 successfully enrolled 302 patients across 25 clinical sites and has now closed enrollment for its 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.

William Stilley, Adial’s Chief Executive Officer, stated, “I am pleased to report we have exceeded our enrollment target of 290 subjects. Given patient interest and because a larger patient population to evaluate AD04 enhances the statistical power of the trial and reduces the risk of not achieving the target number of fully completed patients in the trial, we extended our enrollment period by one month and now, with twelve additional patients enrolled, enrollment of ONWARD is now closed. Our appreciation goes out to the ONWARD clinical investigators across Scandinavia and Central and Eastern Europe, including clinical sites in Sweden, Finland, Poland, Latvia, Bulgaria and Croatia. Our team is highly encouraged by the trial retention rate and safety data to date. This data preliminarily suggests a well-tolerated therapy, which may place Adial’s AD04 at a significant advantage to other currently marketed AUD therapies. Importantly, we remain on target to complete patient dosing in the first quarter of 2022 and look forward to reporting our top line data as soon as practical.”

For more information regarding ONWARD, please visit the National Institute of Health’s Clinical Trials website, which should be updated shortly to reflect full enrollment of the trial.

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