Adial Pharmaceuticals Advances Key Study on Alcohol Use Disorder

Overview of Adial Pharmaceuticals’ Progress

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL), a clinical-stage biopharmaceutical company, is making strides in the treatment of Alcohol Use Disorder (AUD) through its investigational drug AD04. Recently, the company announced a significant milestone with the completion of a database lock in its pharmacokinetics study of AD04. This groundbreaking study aims to assess the drug's effects on heavy drinking patients, specifically targeting those who consume less than ten drinks a day.

Key Milestones Achieved

Cary Claiborne, the President and CEO of Adial, expressed his satisfaction with reaching this milestone, stating that the data has been transferred to independent statisticians for thorough analysis. This analysis is essential as the company prepares for its next round of engagement with the FDA. The upcoming topline results, anticipated in the fourth quarter of 2024, are expected to enhance Adial's clinical strategy for future studies and positions the company favorably for potential partnerships in further development of AD04.

Details of the Pharmacokinetics Study

The pharmacokinetics study involved 30 healthy adult volunteers in an open-label setting, evaluating the drug's bioavailability and dose proportionality. AD04 was administered in varying conditions, both with and without food, compared to a reference standard. Such studies are crucial in establishing a clearer understanding of AD04’s profile, paving the way for its use as a treatment targeting the genetic components of AUD.

About AD04 and Its Potential

AD04 serves as a serotonin-3 receptor antagonist and has shown promise not only in the treatment of AUD but potentially in other addictive disorders, including Opioid Use Disorder and obesity. The investigational drug was previously tested in the ONWARD™ Phase 3 clinical trial, which yielded promising results, indicating its potential efficacy in reducing alcohol consumption among certain patient populations identified via genetic testing.

Strategic Collaborations and Future Plans

As Adial gears up for anticipated results, the focus is also on strategic planning for future collaborations that could support AD04’s clinical development journey. The insights gained from the current study are expected to strengthen the company’s interactions with potential partners and enhance its market position.

Community and Expert Engagement

Adial is committed to engaging with medical professionals and communities affected by addiction disorders. Increased awareness and understanding of the treatments in development are vital for support and education. This effort aligns with their overarching goal to address addiction through innovative pharmaceutical solutions.

Frequently Asked Questions

What is Adial Pharmaceuticals focusing on?

Adial Pharmaceuticals focuses on developing treatments for addiction-related disorders, with AD04 as its lead investigational drug for Alcohol Use Disorder.

What are the results expected from the AD04 study?

Topline results from the pharmacokinetics study of AD04 are expected to be announced in the fourth quarter of 2024.

How does AD04 work?

AD04 acts as a serotonin-3 receptor antagonist, aimed at reducing alcohol consumption in heavy drinkers.

What was the participant profile for the pharmacokinetics study?

The study enrolled 30 healthy adult volunteers to assess AD04's pharmacokinetic profile under different dosing conditions.

How is Adial positioning itself for future trials?

Adial is strategically planning for FDA re-engagement and future collaborations to optimize the development process for AD04.

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