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) -- 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:

Cary Claiborne, CEO of Adial, commented, "Current pharmacological treatments for AUD are limited by low efficacy, poor adherence and adverse effects. This peer-reviewed publication emphasizes the safety and potential of AD04 in addressing the critical needs of individuals suffering from AUD and ALD. With this significant milestone, we are one step closer to providing a precision treatment option that could make a profound impact on the lives of millions worldwide."

"This study report further supports prior data showing that AD04 treatment does not pose significant health risks in patients with AUD. AD04 was well tolerated, and no treatment related serious adverse events were observed. AD04 treatment was not associated with significant changes in liver biochemical parameters, cardiac events, or general well-being. Most importantly, the publication highlighted the potential of AD04 for the treatment for AUD among patients with a specified genetic background. Ultimately, we believe AD04 could pave the way for precision treatments tailored to individuals with AUD, offering a novel strategy to not only manage alcohol consumption but also mitigate liver damage in affected populations," concluded Claiborne.