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Adial Pharmaceuticals Announces Topline Results For Onward™ Phase 3 Trial for AD04 in Patients with Alcohol Use Disorder
AD04 achieved statistically significant mean reduction in heavy drinking days among pre-specified group of heavy drinkers, compared to placebo, with an
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"AD04 achieved statistically significant mean reduction in heavy drinking days among pre-specified group of heavy drinkers, compared to placebo, with an approximately 79% reduction from baseline drinking AD04 demonstrated statistically significant difference in AUD severity, as compared to placebo, with an 84% decrease in the number of heavy drinking patients meeting the criteria for AUD diagnosis Company plans to submit ONWARD results to both European and U.S. regulatory agencies Conference call to be held today at 1:00 p.m. Eastern Time CHARLOTTESVILLE, Va., July 20, 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 successful results from the Company’s ONWARD trial, a 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. AD04 achieved statistically significant mean reduction in heavy drinking days among the pre-specified group of “heavy drinkers” (defined below). AD04 also showed safety and tolerability that compared favorably to placebo. Adial intends to share the results of the ONWARD trial with the relevant health authorities to discuss the appropriate next steps towards the expeditious development of AD04 and to seek product approval. Highlights of topline ONWARD data: AD04 patients, compared with placebo patients, achieved a statistically significant reduction from baseline at month six in heavy drinking days for the pre-specified patient group of heavy drinkers (avg.","length":2247,"tagName":"div"}]