Adial And Cytel Partner To Advance Precision Phase 3 Trial Of AD04 For Alcohol Use Disorder

Adial Pharmaceuticals has made meaningful progress in designing its upcoming Phase 3 trial of AD04, its investigational precision therapy for Alcohol Use Disorder (AUD). To optimize the trial’s success and cost-efficiency, Adial partnered with Cytel Inc., a global leader in advanced clinical trial analytics. Cytel provided data science support to refine key trial design elements and identify genotype-specific patient subgroups likely to respond favorably to AD04.

“Adial’s collaboration with Cytel reinforces our commitment to disciplined capital deployment and data-driven execution. By leveraging advanced analytics and adaptive design, we are in a strong position to generate meaningful clinical data while minimizing time and spend. We believe this strategy materially increases the probability of success for AD04 and creates significant value for patients and shareholders alike,” said Cary Claiborne, CEO at Adial. 

Through post-hoc analysis of prior clinical data and the use of adaptive modeling tools, such as Cytel’s East® platform, the Phase 3 trial will feature a precision-focused and adaptive design. This includes the ability to enrich the trial population mid-study based on interim results, improving the probability of success while aligning with regulatory standards. This approach exemplifies Adial’s commitment to a precision medicine strategy for addiction treatment.

The planned new Phase 3 trial should start in the fourth quarter of 2025 and may include interim analyses to help pursue an expedited regulatory route. AD04, if successful, would be the first-in-class, genetically targeted therapy in AUD, a disorder that millions of people are diagnosed with worldwide and for which existing treatments fail to provide.