AUD is a disease effecting greater than 35 million people in the US alone. For about 33% of this group there is a specific genetic component which Adial has identified and developed a genetic biomarker test which indicates its lead compound AD04 should be highly effective in controlling cravings and heavy and binge drinking, and support abstinence — going straight to the heart and AUD.
The Company’s lead compound AD04 (“AD04”) is a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in a Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company’s proprietary companion diagnostic genetic test. Adial possesses a world-wide, exclusive license from the University of Virginia Patent Foundation to commercialize AD04, subject to FDA approval of the product, based upon three (3) separate patents and patent application families, with patents filed and issued in over 40 jurisdictions, including 3 issued patents in the U.S. AD04 has been used in several investigator-sponsored trials and we possess or have rights to use toxicology, pharmacokinetic and other preclinical and clinical data that supports a Phase 3 clinical trial.
AUD is a potentially multi-billion-dollar market with limited competition & unmet need (accounts for ~5.3% of deaths worldwide and ~5.1% of disease worldwide)
The Lancet reports that alcohol is the number one cause of death in the U.S. & globally among both men and women ages 15 to 49 years
“First step is a test to see if you have a genetic cause for AUD”
“Treatable Genetic-based disease,” rather than a personal weakness or character flaw.
$35 million have AUD in the USA alone, Today about 8% seek treatment, with this new conversation we expect that number to increase.
Designed to reduce craving in order to effectively curb alcohol intake
Ends need for abstinence, a major hurdle in starting & continuing pharmacologic therapy
Brings 20+ year record of acute clinical use with positive safety and tolerability profile
Takes treatment from detox clinics & group therapy- realizes patients’ desire of reduced drinking
Maximal patient compliance, ease of use & increased effect
Companion genetic biomarker test identifies 33% of patients likely to benefit from AD04
Studies suggest that blockade of serotonin-3 receptors will influence the dopamine reward system activated by alcohol, decreasing dopamine release and attenuating craving for alcohol
AD04 believed to interfere with the dopamine reward system and lead to reduced alcohol intake
Run the Phase 3 clinical trials in series, continuing with success
Trial targeting EMA endpoint of reduction of heavy drinking (294 patients)
Data in 2022
Expand trial size (580 patients); powers the study for the U.S. required endpoint*
Data in 2023
Market Launch in 2024
Primary endpoint of severity of drinking measured in drinks per drinking day. Secondary endpoint of frequency of drinking measured in percentage of days abstinence were successfully achieved.
Approval expected to be based on a Heavy Drinking Days (HDD)* Phase 3 end point. Trial not powered for the percentage of HDD; still achieved significance.
Patents expected to prohibit competitors from bringing ondansetron to market for AUD at any dose and also at the AD04 dose
Launch commercially with niche sales forces, expanding with success