Benzinga | Jun 24, 2021 05:12PM EDT

Adial Pharmaceuticals Provides Regulatory And Development Update; Says Has Announced It Received Correspondence Related To Request For Fast Track Designation From FDA; Says Request Was Denied By FDA

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has received correspondence related to its request for Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate, AD04, for the treatment of Alcohol Use Disorder (AUD) in pediatric patients and adult patients with Alcoholic Liver Disease (ALD) with select polymorphisms of the serotonin transporter and receptor genes. While AD04 is being developed and undergoing a pivotal Phase 3 trial to treat any adult with AUD with the targeted genetics, Adial believes AD04 holds the potential to effectively and safely treat AUD patients that are adolescents or have ALD.



The Company is reporting that on June 23, 2021, it received notice from the FDA that its request for Fast Track Designation has been denied at this time. While the FDA did acknowledge the unmet medical needs of adolescents and ALD patients with AUD, the FDA stated in its letter that the Company has not yet demonstrated that the product shows potential to address an unmet medical need in the situation where other treatments are available. Additionally, the FDA stated additional information would be required regarding how AD04 might compare to other therapies if the Company desires further consideration. Based on this feedback, Adial will review the additional requirements and data requested by the FDA for a Fast Track Designation.

The FDA's Fast Track is a process designed to facilitate development and expedite the regulatory review of drugs that treat serious conditions and address unmet medical needs with the purpose of getting important drugs to patients earlier. While the FDA judges the seriousness of a condition on a case-by-case basis, the FDA generally considers whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, left untreated, will progress to a more serious state.

About the Landmark ONWARD(tm) Pivotal Phase 3 Clinical Trial

The ONWARD trial is a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes. Patients are genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients are enrolled. The primary endpoint for analysis of efficacy is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period. ONWARD is currently being conducted in 25 clinical sites in seven countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Estonia, Bulgaria and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.