Patent Issued for Methods of Identifying Patients With Substance Use-Associated Genetic Markers, Treatment With AD04

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The United States Patent and Trademark Office issued patent number 12,221,654 on February 11, 2025, for Adial Pharmaceuticals’ identification of patients with specific genetic markers linked to substance use disorders and treatment with AD04.¹

This new patent expands the covered methods of identifying patients with genetic markers associated with substance use disorders and treating them with AD04, an investigational selective serotonin-3 receptor (5-HT3) antagonist. The AD04 treatment involves first detecting the TT genotype of rs1042173 in the serotonin transporter gene (SLC6A4) and then administering AD04 for individuals with opioid use disorder, alcohol use disorder, and other related conditions.

“This patent is an important milestone for Adial Pharmaceuticals as we continue our mission to create innovative, personalized treatments for addiction,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “Our research not only helps us understand the genetic underpinnings of addiction but also positions us to deliver solutions that are more effective and tailored to individual patients. We believe AD04 has significant potential to treat opioid use disorder and other drug dependencies in addition to our initial indication of alcohol use disorder. By combining genetic diagnostics with precision medicine, we aim to improve outcomes for patients who may not respond to traditional treatments.”

This news comes at the heels of a recent research update on AD04 for the treatment of alcohol use disorder in patients with a 5-HT3 genomic biomarker. In late January, Adial shared results of a pharmacokinetics study that support the near micro-dosing regimen planned for use in the upcoming registration trials for AD04. The study was conducted in 2 phases and enrolled a total of 30 HVs in 2 cohorts. The first phase and cohort 1 (n=6) consisted of a randomized, open-label, 2-sequence, 2-period crossover study evaluating the PK variability of ondansetron in 2 doses of AD04: 0.33 mg and 0.99 mg. The second phase and cohort 2 (n=24) consisted of a randomized, open-label, 6-sequence, 4-period crossover study evaluating the relative bioavailability of AD04 0.33 mg tablets compared with marketed ondansetron 4 mg tablets, the dose proportionality of ondansetron PK between AD04 0.33 mg and 0.99 mg doses, and the food effect on the bioavailability of ondansetron administered as AD04 0.33 mg tablets. Results confirmed that ondansetron pharmacokinetic exposure increased proportionally across a 3-fold AD04 dose range, between AD04 0.33 mg tablets and the marketed ondansetron 4 mg tablets. Investigators demonstrated that AD04 can be taken with or without food.²

Check out all the psychopharmacology updates from January here, and be sure to follow us on LinkedIn, Facebook, or X, or subscribe to our eNewsletters to stay up to date with the latest news.

References

1. Adial Pharmaceuticals awarded new U.S. patent covering genotype-specific treatment of opioid-related disorders. News release. February 12, 2025. Accessed February 12, 2025. https://www.adial.com/adial-pharmaceuticals-awarded-new-u-s-patent-covering-genotype-specific-treatment-of-opioid-related-disorders/

2. Kuntz L. AD04 for alcohol use disorder: new positive results from pharmacokinetics study. Psychiatric Times. January 29, 2025. https://www.psychiatrictimes.com/view/ad04-for-alcohol-use-disorder-new-positive-results-from-pharmacokinetics-study