Adial Pharmaceuticals Administers First Dose in AD04 Alcohol Use Disorder Study

Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company listed on NASDAQ under the ticker ADIL, has commenced a pharmacokinetics study for its lead therapeutic agent, AD04, targeting Alcohol Use Disorder (AUD) in heavy drinking patients. The company announced that the first patient has been dosed, marking a significant milestone in optimizing design elements for upcoming Phase 3 studies in the U.S. and supporting ongoing partnership discussions. The study's topline results are anticipated in early Q4 2024.

Cary Claiborne, the President and CEO of Adial, emphasized the importance of this milestone, highlighting that the data obtained will help design a more precise and informed Phase 3 trial protocol. The study aims to evaluate the optimal dosing regimen to maximize AD04's efficacy and safety in AUD patients. Claiborne also noted that the study aligns with FDA guidance and is a strategic step towards advancing AD04 through the regulatory pathway, specifically under the 505(b)(2) application.

The pharmacokinetics study involves two cohorts conducted consecutively, enrolling up to 30 healthy adult volunteers at a single center. This open-label, relative bioavailability study will compare the pharmacokinetic profile of AD04, administered as a 0.33 mg oral dose taken twice daily, with or without food, against a reference standard product. The study aims to deliver valuable insights into AD04’s pharmacokinetic properties and is expected to be completed by early Q4 2024, with topline results anticipated shortly thereafter.

AD04 (0.33 mg ondansetron taken orally twice daily) acts on the serotonin-3 (5HT3) pathway and is believed to reduce alcohol cravings. This mechanism is distinct from, yet complementary to, currently approved AUD therapies. Post-hoc analyses from previous clinical studies have shown that patients with specific genetic mutations in the 5HT3 receptor, identified as single nucleotide polymorphisms (SNPs) rs1150226-AG (“AG”) or rs1176713-GG (“GG”) genotypes, experienced significant reductions in alcohol consumption. These mutations are thought to affect AD04's binding and function at the 5HT3 receptor. Additionally, AD04 exhibited a safety and tolerability profile comparable to placebo in these trials.

Adial has also developed a companion diagnostic test (CDx) to identify genotypes that benefit from AD04. This CDx was utilized in the Phase 3 ONWARD study and will be implemented in future clinical trials, becoming commercially available upon AD04's launch. The ONWARD study yielded promising results, demonstrating reductions in heavy drinking without significant safety or tolerability concerns.

Adial Pharmaceuticals specializes in developing treatments for addiction and related disorders. AD04, the company's leading investigational product, is a genetically targeted serotonin-3 receptor antagonist. It has shown potential not only for treating AUD but also for other addictive disorders such as Opioid Use Disorder, gambling, and obesity. The company remains focused on advancing AD04 through clinical trials and regulatory approvals, aiming to bring this innovative treatment to market.

In summary, Adial's pharmacokinetics study for AD04 is a crucial step in refining the drug's dosing regimen, enhancing its efficacy and safety profile, and supporting future Phase 3 trials. The study's results will play a key role in regulatory discussions with the FDA, ultimately advancing AD04 towards potential approval and commercialization.