Adial Pharmaceuticals (ADIL) Announces Database Lock for the ONWARD Trial

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) today announced database lock for the Company’s ONWARD Phase 3 clinical trial. The data sets have been transferred to the Company’s independent, external statistical consultants who have initiated the analysis of the data. Adial anticipates that it will provide top-line results in July 2022.

“We are excited that data analysis has commenced and we look forward to reporting the topline results of ONWARD this July,” said Dr. Bankole Johnson, Chief Medical Officer of Adial. “The primary endpoint of the ONWARD trial is reduction from baseline in the monthly number of heavy drinking days experienced by each patient during the last eight weeks of the 24-week treatment period. Secondary endpoints include reduction in total alcohol consumed and improvement as measured by the Patient Health Questionnaire-9, a widely accepted tool for assessment of depression. I am also pleased to reaffirm that no drug-related serious adverse events were reported during the 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 and selected polymorphisms in the serotonin transporter and receptor genes. Patients were genetically screened prior to enrollment in the ONWARD trial so that only genetically positive patients were enrolled. Approximately one-third of the screened patients tested genetically positive for the targeted genetics.

ONWARD was conducted in 25 clinical sites in six countries in Scandinavia and Central and Eastern Europe (Sweden, Finland, Poland, Latvia, Bulgaria and Croatia). The principal investigator is Professor Hannu E.R. Alho, Emeritus Professor of Addiction Medicine at the University of Helsinki.

The ONWARD trial is expected to serve as a basis for approval of AD04 for the treatment of Alcohol Use Disorder in patients identified as having the targeted genetics (i.e., a pivotal Phase 3 trial).

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