By Ben Glickman


Adial Pharmaceuticals said it would conduct two additional Phase 3 trials for its alcohol use disorder treatment after receiving feedback from U.S. and European regulators.

The Charlottesville, Va.-based biopharmaceutical company, which has already conducted a Phase 3 trial of AD04, said the two trials would target different patient groups and address questions from regulators around efficacy.

AD04 is a genetically targeted treatment for alcohol use disorder. Adial said regulators requested additional data on AD04 and the trials would be conducted in parallel to increase the likelihood of approval in the U.S. and Europe in the shortest possible timeframe.

The company said it would prioritize approval and register AD04 with the U.S. Food and Drug Administration by the third quarter of 2025 if both trials are successful, as U.S. standards "should translate to acceptance in other international markets."

The FDA has confirmed AD04's primary endpoint of a reduction in the number of heavy drinking days to zero in patients by months five and six on the treatment, the company said.

The trials are expected to cost about $25 million and commercial partners are in talks about potentially supporting the trials and the drug's later commercialization, the company added.

Shares of Adial were up 7.6% to 22 cents in pre-market trading Tuesday.


Write to Ben Glickman at ben.glickman@wsj.com


(END) Dow Jones Newswires

07-11-23 0942ET