ADial Pharmaceuticals, LLC ("ADial"), announced today that the U.S. Food and Drug Administration ("FDA") has agreed to allow ADial to move forward with its plan to initiate Phase III trials of AD04 as a treatment for alcohol use disorder ("AUD") in certain targeted genotypes population only. Patients will initially be screened for the targeted genotypes and only those with one or more of the targeted genotypes will be enrolled in the trial. Enrolled patients will then be randomized between the active drug and placebo. Performing the Phase III trial in only the targeted genotypes significantly reduces the trial size and associated costs and risk of the trial.
The two endpoints for demonstrating the efficacy of AD04 in the trial are percent of heavy drinking days ("PHDD") and the percent of subjects with no heavy drinking days ("PSNHDD") in the final two months of the trial. For both endpoints, a heavy drinking day is defined as a day with 4 or more drinks for women or 5 or more drinks for men. The European Medicines Authority ("EMA") has accepted PHDD as a primary endpoint for approval of drugs for the treatment of alcohol dependence and the FDA has stated that PSNHDD is an acceptable endpoint for demonstrating efficacy of AD04 in the US.
Two successful Phase III trials will be required for approval of AD04. Each trial will be 24 weeks in duration and will enroll approximately 600 patients.
"The ability to launch the Phase III trials only in subjects having the targeted genotypes represents an important breakthrough for the Company and for this promising new therapy for Alcohol Use Disorder," said William Stilley , Chief Executive Officer. "Planning is underway to commence Phase III trials later this year."
ADial Pharmaceuticals, LLC