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New results are coming for AD04, a potential treatment for patients with alcohol use disorder.
Adial Pharmaceuticals announced it plans to report topline results from their ONWARD phase 3 clinical trial on Wednesday, July 20, 2022.1 The ONWARD phase 3 clinical trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, clinical study to evaluate the efficacy, safety, and tolerability of AD04 in patients with alcohol use disorder and selected polymorphisms in the serotonin transporter and receptor genes.
Study participants were genetically screened prior to enrollment to ensure that only genetically positive patients were enrolled. Approximately one-third of the screened participants tested positive for the targeted genetics. Patients were also stratified by the severity of drinking into heavy drinkers and very heavy drinkers, which was defined by an average of less than 10 or greater than or equal to 10 drinks per day, respectively. Approximately, two-thirds of the patients in the ONWARD trial were in the heavy drinking group and one-third in the very heavy drinker group.
ONWARD was conducted in 25 clinical sites across 6 countries in Scandinavia, Sweden, Finland, Poland, Latvia, Bulgaria and Croatia. Professor Hannu E.R. Alho, MD, Emeritus Professor of Addiction Medicine at the University of Helsinki, is the principal investigator.
1. Adial Pharmaceuticals to announce topline results of ONWARD™ phase 3 trial for AD04 in patients with alcohol use disorder. Adial. July 18, 2022. https://www.adial.com/adial-pharmaceuticals-to-announce-topline-results-of-onward-phase-3-trial-for-ad04-in-patients-with-alcohol-use-disorder/