Adial Pharmaceuticals Completes Crucial Pharmacokinetic Study for AD04, Advancing Alcohol Use Disorder Treatment
In a significant step forward for its alcohol use disorder (AUD) treatment program, Adial Pharmaceuticals Inc. (ADIL) has announced the successful completion of a pharmacokinetic (PK) study for its drug candidate AD04. This study, conducted in heavy drinking patients, provides critical data that will inform the design of upcoming Phase 3 clinical trials for AD04.
The completion of this study marks a key milestone for Adial Pharmaceuticals, as it fulfills a requirement set by the Food and Drug Administration (FDA). The data generated will be instrumental in optimizing the design elements of the Phase 3 trials, ultimately enhancing the chances of successful clinical outcomes and potentially paving the way for a faster approval process.
The study, a single-center, relative bioavailability, open-label trial, enrolled 30 healthy adult volunteers in two cohorts. The study design allowed researchers to evaluate the variability in ondansetron levels (the active ingredient in AD04) from different doses of the drug, as well as its relative bioavailability compared to a standard ondansetron tablet. Importantly, the study also assessed the impact of food on the absorption of AD04.
The results of the study demonstrated several key findings:
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Lower Dose, Lower Exposure:
Due to its lower dose, AD04 0.33mg delivered lower ondansetron PK exposure compared to the marketed ondansetron 4mg tablet. This finding suggests that AD04 may offer a more tailored approach to managing AUD, potentially mitigating the risk of side effects associated with higher doses.*
Dose Proportionality:
The study confirmed that ondansetron pharmacokinetic exposure increased proportionally with dose across a 3-fold range of AD04 doses. This data supports the feasibility of optimizing AD04 dosing to achieve desired therapeutic effects in patients.*
Food Flexibility:
The results demonstrated that AD04 can be taken in both fed and fasted states, offering flexibility and convenience for patients.The completion of this relatively short and cost-effective study is a key part of Adial Pharmaceuticals’ strategy to advance ongoing partnerships and potentially secure approval for AD04 under the 505(b)(2) regulatory pathway. This pathway allows for the approval of a drug based on data previously submitted for a similar drug, potentially accelerating the approval process.
In the fourth quarter of 2024, Adial Pharmaceuticals plans to engage with the FDA to share the results of this PK study and obtain feedback to further refine the AD04 Phase 3 study program. These discussions will be crucial in determining the next steps for AD04’s development and its potential to become a valuable treatment option for individuals with AUD.
The news of the completed PK study has been well-received by the market, with ADIL stock trading slightly down in premarket trading. The stock’s performance will likely be influenced by investor sentiment surrounding the upcoming Phase 3 trials and the potential for FDA approval.
