Adial Pharmaceuticals completes AD04 demonstration batch production

Adial Pharmaceuticals (ADIL) announced completion of the demonstration batch production for AD04. The results of the batch confirmed that the transferred process met the targeted specifications for the planned Phase 3 clinical batch and matched the dissolution profile of the previous Phase 2 batch, thereby demonstrating a technical process transfer. This important step was required prior to manufacturing the batch production for the planned Phase 3 clinical program. The tech transfer of the manufacturing and analytical capability for AD04 to a new CDMO resulted in significant efficiencies and crossing the hurdle of dissolution, blend and content uniformity which will have a meaningful clinical and commercial impact for AD04, once approved for patients suffering from AUD. This achievement enables the production of the clinical and registration batches which are required to conduct the clinical trial as well as the needed data for updates to the IND for AD04 with the Food and Drug Administration.