Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) announced a partnership with Catalent Pharma Solutions, a leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, to advance clinical activities related to AD04, Adial’s genetically targeted, lead investigational new drug product for the treatment of alcohol use disorder (“AUD”). This partnership brings together critical 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 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,” commented William Stilley, CEO of 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.
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