With research showing that addictive behavior can be treated effectively with medication, ADial is developing a combination compound that affects the reward center of the brain, thereby decreasing the craving for alcohol and reducing alcohol consumption. The medication appears to be effective because of its synergistic mechanisms –targeting multiple neurological pathways in the brain, thereby enhancing efficacy while reducing side effects. In addition, the medication can be given to patients currently drinking. This significant improvement not only increases access to treatment; it increases the likelihood of success, which can now be measured as a reduction in alcohol consumption and control over one’s drinking.

AD/TO:01 is a proprietary combination of topiramate and ondansetron .
ADial’s lead candidate drug (AD/TO:01) shows a benefit for 1 out of 2 patients treated vs. currently marketed drugs that only benefit (approximately) 1 out of 10.

AD/TO:01 Status

Phase		Status	Timing
Pre-clinical*	First trials undertaken to determine drugs effects conducted in a laboratory or through controlled animal studies.	completed
Phase 0*	First-in-human trials undertaken to provide an early indication of new drugs effects in humans.	completed
Phase I*	Limited number human trials aimed at evaluating the safety, tolerability and effects of a new drug.	completed
Phase II*	Limited number of human trials undertaken to evaluate the effect of the combination drug vs either drug alone and vs placebo.	underway	Target completion date for this 300 patient study is the 2nd Quarter 2009. Currently 100 patients are enrolled.
Phase III	Randomized controlled trials on large patient groups to determine the definitive assessment of the efficacy of the new drug and garner results in support of a New Drug Application (NDA) and marketing approval.	under preparation	Scheduled to be launched during 2010 with completion targeted for 2012.