Adial Pharmaceuticals, a biopharmaceutical company based in Charlottesville, VA, has announced its plans to conduct two additional Phase 3 trials for its alcohol use disorder treatment, AD04, following feedback from regulators in the U.S. and Europe. The objective of these trials is to target different patient groups and address questions raised by regulators regarding the treatment’s efficacy.
AD04 is a genetically targeted treatment specifically designed for alcohol use disorder. In response to requests for additional data on AD04 from regulators, Adial has decided to conduct these two trials in parallel. The company hopes that this approach will increase the chances of obtaining approval in both the U.S. and Europe within the shortest possible timeframe.
Adial Pharmaceuticals has made it clear that their priority is to obtain approval and register AD04 with the U.S. Food and Drug Administration (FDA) by the third quarter of 2025, should both trials prove successful. They believe that approval by the FDA will facilitate acceptance in other international markets.
The primary endpoint specified by the FDA for AD04 is a reduction in the number of heavy drinking days to zero within five to six months of treatment. Adial Pharmaceuticals is confident that AD04 meets this requirement.
The estimated cost of conducting these two Phase 3 trials is approximately $25 million. Adial is currently in talks with potential commercial partners who may be interested in supporting the trials and participating in the later stages of drug commercialization.
In pre-market trading on Tuesday, shares of Adial Pharmaceuticals saw an increase of 7.6% to 22 cents.