Adial Pharmaceuticals announces database lock in PK study of AD04

Adial Pharmaceuticals announced database lock for the pharmacokinetics, PK, study of AD04, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder, AUD, in heavy drinking patients. Topline results are expected to be announced during the fourth quarter of 2024. Cary Claiborne, President and Chief Executive Officer of Adial, said, “We are pleased to announce database lock for our pharmacokinetics study. The data has now been transferred to independent statisticians, who will begin the data analysis process for our next FDA interaction. As we prepare for the release of topline results in the fourth quarter, our attention turns to the next critical steps, including planning for re-engagement with the FDA. The insights gained from this study will be crucial in shaping our clinical strategy for the Phase 3 study. In addition, we believe the topline results, will strengthen our position for potential strategic collaborations as we finalize planning efforts for the future clinical development of AD04.”