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Adial Pharmaceuticals Announces Peer-Reviewed Publication Highlighting Promising Safety Data and High Patient Compliance in a Clinical Trial of AD04 as a Potential Treatment for Alcohol Use Disorder
Findings underscore the liver safety of AD04 as compared to placebo in the prior Phase 3 clinical trial GLEN ALLEN, Va., April 10, 2024 (GLOBE NEWSWIRE) --
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"Findings underscore the liver safety of AD04 as compared to placebo in the prior Phase 3 clinical trial\nGLEN ALLEN, Va., April 10, 2024 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announced the publication of a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD04 (low-dose ondansetron), the Company’s lead investigational new drug product being developed for the treatment of Alcohol Use Disorder (AUD). The publication also reported the results of a new study analyzing the liver safety profile of AD04 compared with placebo in subjects with AUD in the Company’s prior Phase 3 clinical trial. The published study provides a comprehensive analysis of the liver safety profile of AD04 compared to a placebo in individuals with AUD and a specific 5-marker genetic profile. AUD, characterized by compulsive alcohol consumption and loss of control over intake, poses significant health risks and is a major contributor to alcohol-associated liver disease (ALD), a leading cause of liver transplantation and global mortality. According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin. Additionally, while patients with AUD displayed elevated GGT levels, typically associated with increased alcohol consumption, this parameter remained unaffected by low-dose AD04. Additionally, no significant adverse effects were observed due to oral low-dose AD04 treatment. The publication also highlighted that low-dose AD04 demonstrated an outstanding safety and tolerability profile compared to placebo, featuring a low occurrence of adverse events (AEs), high medication compliance, and a minimal dropout rate. The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar AE profile to a placebo. The manuscript entitled, “Safety and compliance of long-term low-dose ondansetron in alcohol use disorder treatment,” was published in the European Journal of Internal Medicine. The publication is available via Open Access at: https://www.ejinme.co...