Adial completes AD04 demonstration batch production for planned Phase 3 trial
Adial Pharmaceuticals completed demonstration batch production for AD04, meeting prespecified specifications and matching the prior Phase 2 dissolution profile. The step enables clinical and registration batch production for the planned Phase 3 trial.
Adial Pharmaceuticals announced the successful completion of the demonstration batch production for AD04, enabling clinical and registration production for the planned Phase 3 trial. The results of the batch confirmed that the transferred process met the targeted specifications for the planned Phase 3 clinical batch and registration campaign and matched the dissolution profile of the previous Phase 2 batch.
The demonstration batch met prespecified dissolution, content uniformity, and blend uniformity specifications. The company said this confirmed a successful technical transfer to a new contract development and manufacturing organization and enables production of clinical and registration batches and IND updates with the FDA.
AD04 is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder in heavy drinking patients. The company said AD04 was recently investigated in the ONWARD pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the company’s companion diagnostic genetic test.
The company said AD04 also has potential applications for other addictive disorders, including Opioid Use Disorder, gambling, and obesity.