Adial Completes AD04 Demonstration Batch Meeting All Spec Targets for Phase 3
Adial Pharmaceuticals completed demonstration batch production for AD04 under a new CDMO, achieving prespecified dissolution, content uniformity and blend uniformity targets identical to the Phase 2 profile. This successful technical transfer clears the way for clinical and registration batch manufacturing for the planned Phase 3 trial and FDA IND updates.
1. Successful Demonstration Batch Production
Adial Pharmaceuticals completed the demonstration batch for its lead investigational product AD04, with all prespecified criteria—dissolution profile, content uniformity and blend uniformity—meeting regulatory standards and matching the Phase 2 profile. This confirms the robustness of the manufacturing process prior to clinical-scale production.
2. CDMO Transfer and Manufacturing Efficiency
The technical process transfer to a new contract development and manufacturing organization delivered significant efficiencies, clearing critical manufacturing hurdles and validating analytical methods. Achieving these targets underscores the scalability and reproducibility of AD04’s production ahead of larger batch runs.
3. Next Steps: Phase 3 Trial and IND Updates
With demonstration batch success secured, Adial can proceed to produce both clinical and registration batches required for the planned Phase 3 trial. These batches will support IND amendments and pivotal efficacy studies in alcohol use disorder, accelerating progression toward regulatory submissions.