Adial begins pharmacokinetic study for AUD treatment By Investing.com

GLEN ALLEN, Va. – Adial Pharmaceuticals, Inc. (NASDAQ:), a clinical-stage biopharmaceutical company, announced the dosing of the first patient in a pharmacokinetic study of AD04, a genetically targeted therapy for Alcohol Use Disorder (AUD). The study aims to refine the design of the upcoming pivotal Phase 3 trials and is expected to be completed in early Q4 2024.

The study will assess the pharmacokinetic profile of AD04, which is taken orally twice daily, in up to 30 healthy adult volunteers. It will compare the absorption, distribution, metabolism, and excretion of the drug, with or without food, to a reference product. This data is crucial for optimizing the Phase 3 trial protocol and for a potential application for FDA approval under the 505(b)(2) regulatory pathway.

AD04 acts on the serotonin-3 receptor and is designed to reduce alcohol craving in patients with certain genetic profiles. Post-hoc analyses of previous clinical trials have suggested that AD04 is particularly effective in patients with specific single nucleotide polymorphisms in the 5-HT3A receptor subunit gene.

Cary Claiborne, President and CEO of Adial, stated that this study is a significant step towards developing a precise Phase 3 trial protocol and enhancing the drug’s likelihood of success. The company also plans to engage with the FDA in Q4 2024 to discuss the study results and finalize the Phase 3 design.

In addition to treating AUD, AD04 may have the potential to address other addictive disorders, such as Opioid Use Disorder, gambling, and obesity. Adial has developed a companion diagnostic test to identify patients who are most likely to benefit from AD04, which was used in its ONWARD Phase 3 clinical trial and will be available commercially upon the drug’s launch.

The announcement is based on a press release statement from Adial Pharmaceuticals. The company has cautioned that forward-looking statements involve risks and uncertainties, and actual results may differ materially from those anticipated. These statements reflect current views and are subject to change.

InvestingPro Insights

As Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) forges ahead with the development of AD04 for Alcohol Use Disorder, the company’s financial health and stock performance provide a backdrop to the clinical progress. With a market capitalization of 5.51 million USD, Adial is navigating the biopharmaceutical industry with a focus on strategic growth. Despite the challenges faced in the sector, one of the InvestingPro Tips highlights that Adial holds more cash than debt on its balance sheet, which could provide a level of financial stability as it moves towards pivotal Phase 3 trials.

Investors tracking ADIL’s stock have witnessed a significant return over the last week, with a price total return of 13.33%. This may signal a growing investor confidence in the short term, even as the stock has experienced a steep decline over the past year, with an 81.24% drop in the price total return. The stock’s price volatility is another factor to consider, as indicated by another InvestingPro Tip, which could impact investment decisions for those seeking either short-term opportunities or long-term holdings in the biopharmaceutical space.

The company’s financial performance, as reflected by the adjusted price-to-earnings (P/E) ratio of -0.49 for the last twelve months as of Q1 2024, and an operating income of -6.46 million USD, underscores the challenges typical of clinical-stage companies that are yet to reach profitability. Adial’s strategic focus on genetically targeted therapies for AUD and other addictive disorders is a key aspect to watch as the company endeavors to reach a favorable outcome in its upcoming FDA engagements.

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