Adial CEO Cary Claiborne on Treating Alcohol Addiction with Genetics

What It Covers

Adial Pharmaceuticals CEO Cary Claiborne explains how AD04, a repurposed low-dose ondansetron, targets a specific genetic biomarker found in roughly 14% of the estimated 30 million Americans with alcohol use disorder.

Key Questions Answered

• •Genetic targeting via companion diagnostic: AD04 only works for patients carrying a specific genotype, identified through a cheek swab test administered before prescribing. Physicians report this reframes AUD from a moral failing to a biological condition, reducing patient resistance and opening treatment conversations.
• •No abstinence requirement: Unlike all currently approved AUD medications, AD04 does not require patients to stop drinking before starting treatment. It targets craving reduction and diminished pleasure response to alcohol, aiming for moderation rather than immediate abstinence, lowering the adoption barrier significantly.
• •AI-assisted Phase 3 trial design: Adial used machine learning to run simulations across existing clinical data to confirm the 14% target genotype and optimize Phase 3 study design. This approach objectively validated internal assumptions and increased organizational confidence before committing to a large, costly trial.
• •Indication expansion roadmap: Because AD04 acts on dopamine reward pathways, Adial sees potential future applications in opioid use disorder, compulsive eating, and gambling addiction. A long-acting delivery format, similar to monthly opioid treatments, is also under consideration to reduce daily dosing relapse risk.