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Adial Pharmaceuticals Announces Greater Than 50% of Patients Expected to Complete ONWARD™ Phase 3 Trial of AD04 for the Treatment of Alcohol Use Disorder Have Completed the Full 24-Week Treatment Period – Trial Completion Anticipated Q1 2022
CHARLOTTESVILLE, Va., Sept. 30, 2021 (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., Sept. 30, 2021 (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, announces that greater than 50% of patients expected to complete the 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 have completed the full, 24-week, treatment period. ONWARD is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, pivotal Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of AD04 in patients with AUD and selected polymorphisms in the serotonin transporter and receptor genes. The intended primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days (HDDs) during the last 8 weeks (weeks 16-24) of the 24-week treatment period, where heavy drinking is defined as the consumption of 5 or more drinks/day for men and 4 or more drinks/day for women. Drinking levels are self-reported using the timeline follow-back (TLFB) method. The TLFB method is a daily calendar for alcohol consumption and employs memory aids to prompt recall. The TLFB has been used extensively in pharmacotherapy trials for AUD and other substance abuse disorders. Baseline is the 4-week period prior to the screening visit. For each subsequent clinic visit, alcohol consumption is recorded as the number of drinks per day. Patients have been randomized based on a one-to-one (placebo-to-AD04) ratio, so that approximately 50% of enrolled patients will be in the placebo group and 50% in the AD04 group. Both placebo and active clinical trial material were manufactured in two batches of equal amounts and are light-yellow, oval tablets for oral administration with each tablet weighing approximately 80 mg. Placebo and active tablets are indistinguishable from each other. The active tablets have 0.33 mg of AD04’s active ingredient, Ondansetron, in place of a similar volume of excipient (i.e., starch) in the placebo. They have been packaged in blister-packs of 18 tablets, which allows for 7-days of dosing plus 2-days extra to al...