Adial Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of medicines for addiction, has formed a partnership with Catalent Pharma Solutions to advance clinical activities related to AD04, Adial’s genetically targeted, lead investigational new drug product for the treatment of alcohol use disorder (AUD). The partnership will allow the commencement of Adial’s planned initial Phase 3 trial, with Catalent providing packaging and distribution services.
 
Based on the clinical experience to date and publicly available databases, Adial believes the genetic prevalence of genotype-positive AUD patients in the U.S. is about 33%, or about 11 million 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 U.S. Food and Drug Administration (FDA) has agreed that the Phase 3 trials of AD04 can proceed with enrolling patients that are genotype positive for this Phase 3 trial.
 
“The FDA’s agreement to allow Adial to structure our Phase 3 trial of AD04 by inclusion of only genotype-positive patients significantly reduces the cost, time and risk as compared with having to enroll patients in the study that are genotype-negative for potential treatment with AD04,” said William Stilley, chief executive officer, Adial Pharmaceuticals.
 
Adial plans to commence the initial Phase 3 trial of AD04 in Scandinavia and Eastern Europe during the first half of 2019. Adial selected these geographic areas premised on the expected higher prevalence of genotype positive patients, which will help to reduce the cost, time and risk to achieve Phase 3 results.
 
Catalent has a robust, global network, with the presence in Europe and the U.S. to provide flexible, integrated clinical supply services for investigational medicinal products. Catalent will be responsible for packaging and distributing AD04 to clinical sites. With additional facilities in the Asia/Pacific region and in Latin America, Catalent provides capabilities that should also be important in the future development of AD04, and for the eventual commercial launch of the product, once approved.
 
“We look forward to continuing our long-term relationship with Catalent, which will provide critical distribution and logistics support for AD04 in our upcoming Phase 3 trial,” said Mr. Stilley. “With facilities and personnel servicing Scandinavia and Eastern Europe, Catalent is an ideal partner; we believe that its packaging and logistics expertise and GMP facilities are well equipped to support our planned clinical sites. In addition, Catalent brings broad capabilities in the U.S. and globally, which should be important as we seek to expand our clinical development activities and initiate commercialization promptly upon approval.”
 
Paul Hegwood, president, clinical supply services, Catalent, said, “Catalent is pleased to enter this partnership and we look forward to working with Adial as it drives to bring this new drug product to patients for the treatment of alcohol use disorder.”