Adial Pharmaceuticals Inc. | A fresh start for alcohol use disorder

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Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of a therapeutic agent for the treatment of alcohol use disorder “AUD” using our lead investigational new drug product, AD04. A Phase 2b University of Virginia investigator sponsored clinical trial of AD04 for the treatment of AUD showed promising results and no overt safety concerns (there were no statistically significant serious adverse events reported). The Company plans to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes.

Genetically Targeted

Designed to reduce craving to effectively curb alcohol intake in the approximately 33% of patients with the genetics expected to indicate a likely response to treatment with AD04

BRINGS 20+ YEAR TRACK RECORD OF CLINICAL USE

To date, clinical testing of AD04 has shown it to have a positive safety and tolerability profile with side effects similar to placebo.

Oral daily dosing

Our product candidate is intended to be easy to use since it is administered orally.

AUD is characterized by an urge to consume alcohol and an inability to control the levels of consumption

AD04 Ready to Enter Phase 3 in Targeted Groups

Adial is preparing to commence a Phase 3 clinical trial using AD04 for the potential treatment of AUD in subjects with certain target genotypes.

Adial has created an investigational attendant diagnostic biomarker blood test for the genetic screening of patients with certain biomarkers that, as reported in the American Journal of Psychiatry (Johnson, et. al. 2011 & 2013), Adial believes make patients more likely to benefit from treatment with AD04.

Adial’s strategy is to integrate pre-treatment genetic screening into AD04’s label to create a patient-specific treatment in one integrated therapeutic offering. Adial’s goal is to develop a genetically targeted, effective and safe product candidate to treat AUD that does not require abstinence as part of the treatment.