23 January, 2021
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the treatment and prevention of addictions. The Company’s lead investigational new drug product, AD04, is currently in Phase 3 development as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD). A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency and quantity of drinking and heavy drinking with no overt safety concerns.
Genetically Targeted
Designed to reduce craving to effectively curb alcohol intake in those 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
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Adial's plan is to run a Ph 3 trial of AD04 for the treatment of alcohol use disorder (AUD), targeted at reducing the mean number of heavy drinking ...days. Learn about our next steps & potential commercialization strategy of AD04 for AUD once approved https://youtu.be/YM6UWNjJ0zE $ADIL
Adial to file an application for “Fast Track” with the U.S.FDA for its lead drug candidate, AD04, which is a therapeutic agent for the treatment ...of Alcohol Use Disorder (AUD) in persons with certain target genotypes. #PersonalizedMedicine $ADIL 1/3
Adial to File Fast Track Application for AD04 with the FDA
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Our lead drug candidate, AD04, is currently being investigated in a pivotal Ph 3 trial in Europe for the treatment of AUD. AD04 is designed to reduce... cravings in order to effectively curb alcohol intake. Learn more: https://www.adialpharma.com/technology/ #addictionmedicine $ADIL #alcoholism
AD04 Ready to Enter Phase 3 in Targeted Groups
Adial has commenced 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.