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Adial Pharmaceuticals Announces Completion of Last Patient, Last Visit in its ONWARD™ Phase 3 Trial of AD04 for the Treatment of Patients with Alcohol Use Disorder
CHARLOTTESVILLE, Va., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"CHARLOTTESVILLE, Va., Feb. 24, 2022 (GLOBE NEWSWIRE) -- 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, today announced that the final patient has completed the last dose and last clinical visit in the Company’s ongoing ONWARD™ Phase 3 trial. ONWARD is evaluating the efficacy, safety and tolerability of 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, “Last patient, last visit in the ONWARD trial is a major milestone for the Company. As previously announced, we had enrolled 302 patients across 25 clinical sites, exceeding our prior enrollment targets and, therefore, enhancing the statistical power of the trial. The safety data and trial retention rate also suggest a well-tolerated therapy, in contrast to conventional therapies. We are now turning our attention to safety follow-up protocols and close-out activities with the expectation that topline results will be available in the second quarter.” “Patients suffering from AUD remains a significant yet underserved market, accounting for over 3 million deaths worldwide. Sadly, AUD is also the number one risk factor for death and disability in the U.S., and globally among men and women ages 15 to 49. Given the magnitude of this public health crisis, which has only increased since the start of the pandemic, it is more important than ever to bring AD04 to market for the patients. My sincerest gratitude goes to the patients and clinicians that participated in this important trial,” continued Mr. Stilley. “While the last patient, last visit has occurred, the study will remain blinded until the completion of all safety protocol follow-up activities, site inspections, protocol review and other trial closing procedures and activities. Then the database will be locked and analysis of the data will take place. The goal is to show a statistically significant reduction in the number of days of heavy drinking over the course of the study in patients on active AD04 as compared to the placebo group.” About the Landmark ONWARD™ Pivotal Phase 3 Cli...