Adial Pharmaceuticals announces partnership with Catalent for AD04
Adial Pharmaceuticals announced a partnership with Catalent Pharma Solutions, a provider of delivery technologies and development solutions for drugs, biologics and consumer health products, to advance clinical activities related to AD04, Adial's genetically targeted, investigational new drug product for the treatment of alcohol use disorder, or AUD. This partnership brings together capabilities to allow the commencement of Adial's planned initial Phase 3 trial, with Catalent providing packaging and distribution. Based on the clinical experience to date and publicly available databases, Adial believes the genetic prevalence of genotype-positive AUD patients in the United States is about 33%, or about 11M people, and that the prevalence in Scandinavia and in certain areas of Eastern Europe may be even higher, with possibly more than 50% being genetically positive for treatment with AD04. The FDA has agreed that the Phase 3 trials of AD04 can proceed with enrolling patients that are genotype positive for this Phase 3 trial.