Peer-reviewed publication highlighting promising safety data and high patient compliance in a clinical trial of AD 04 as a potential treatment for alcohol use disorder

The publication also reported the results of a new study analyzing the liver safety profile of AD 04 compared with placebo in subjects with AUD in the Company’s prior Phase III clinical trial. The published study provides a comprehensive analysis of the liver safety profile of AD 04 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 AD 04 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 AD 04. Additionally, no significant adverse effects were observed due to oral low-dose AD 04 treatment. The publication also highlighted that low-dose AD 04 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.com/article/S0953-6205(24)00123-7/fulltext.

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 AD 04 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 AD 04 treatment does not pose significant health risks in patients with AUD. AD 04 was well tolerated, and no treatment related serious adverse events were observed. AD 04 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 AD 04 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.