Positive Results From Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder

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Adial Pharmaceuticals today announced that it has completed a pharmacokinetics (PK) study of AD04, an investigational genetically targeted, serotonin-3 receptor antagonist, and therapeutic agent for the treatment of alcohol use disorder (AUD) in patients with heavy drinking. This data will help guide the study design for the upcoming phase 3 clinical trial of AD04.¹

“Completion of this study achieves our goal to obtain the data we needed to design a more precise and informed phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Its completion is in accord with previous guidance provided by the FDA and is intended to enhance the likelihood of success in our upcoming phase 3 trial,” said Cary Claiborne, president and chief executive officer of Adial.

In this single-center, relative bioavailability, open label study, investigators enrolled a total of 30 healthy adult volunteers in 2 cohorts. Heavy drinking was defined as less than 10 drinks/drinking day. Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99 mg. Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33 mg tablet to a marketed ondansetron 4 mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99 mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33 mg tablet. Results showed that, because of the lower dose, AD04 0.33 mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4 mg tablet. Furthermore, ondansetron PK exposure increased in proportion to dose across a 3-fold AD04 dose range. Lastly, AD04 can be taken in fed or fasted states.

“This relatively short and low-cost study was a key element of our strategy to advance ongoing partnership discussions. Additionally, the study will provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA. We plan to engage with the FDA during Q4 2024 with the results of this pharmacokinetics study and obtain feedback which will assist with the AD04 phase 3 study program. This meeting is an important next step to further advancing AD04 towards regulatory approval,” said Claiborne.

According to the World Health Organization, harmful alcohol consumption causes 3 million deaths—or 5.3% of all deaths—globally every year, and 5.1% of the global burden of injury and disease is attributable to alcohol.² Explore the latest expert discussions on and treatment updates for AUD and harmful alcohol consumption in Psychiatric Times here.

References

1. Adial Pharmaceuticals announces positive topline results from the AD04-103 pharmacokinetics study of AD04 for the treatment of alcohol use disorder. News release. November 14, 2024. https://www.adial.com/adial-pharmaceuticals-announces-positive-topline-results-from-the-ad04-103-pharmacokinetics-study-of-ad04-for-the-treatment-of-alcohol-use-disorder/

2. Alcohol. World Health Organization. May 9, 2022. Accessed November 14, 2024. https://www.who.int/news-room/fact-sheets/detail/alcohol