A completed PK study of AD04 demonstrated lower ondansetron exposure and flexible dosing across a 3-fold range in fed or fasted states.
On Tuesday, Adial Pharmaceuticals, Inc. ADIL announced that patent number 12150931 was issued by the United States Patent and Trademark Office on November 26, expanding the company's intellectual property coverage.
The patent covers a broader range of genotype combinations identified by the company's proprietary genetic diagnostic for targeted treatment of alcohol use disorder (AUD) with AD04, the company's lead investigational new drug product.
Also Read: EXCLUSIVE: Adial Pharmaceuticals Advances Regulatory Strategy For Companion Diagnostic Genetic Test For Its Lead Program For Alcohol Use Disorder
These genotype combinations include the HTR3A, HTR3B, and SLC6A4 receptor sites, which are expected to play an important role in the company's precision medicine approach to treating addiction and may support the expansion of its pipeline.
"This patent significantly enhances our intellectual property portfolio, providing us with greater flexibility and protection as we advance AD04 toward commercialization," said Cary Claiborne, CEO of Adial Pharmaceuticals.
The company says it has expanded patent coverage for AD04, focusing on its use in personalized medicine. This new patent strengthens the company's strategy to protect AD04 for treating AUD by covering all genotype combinations identified in our clinical program, ensuring intellectual property protection through 2031.
In November, Adial Pharmaceuticals completed a pharmacokinetics (PK) study of AD04 for Alcohol Use Disorder in heavy drinking patients (defined as less than ten drinks/drinking day).
The results showed that, due to the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3-fold AD04 dose range; and AD04 could be taken in fed or fasted states.
Price Action: At last check on Tuesday, ADIL stock was down 0.93% at $1.06 during the premarket session.
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