Adial Pharmaceuticals' ( NASDAQ: ADIL ) AD04 could not show statistical significance in reducing heavy drinking days, compared to placebo, in very heavy drinkers in a phase 3 trial in patients with Alcohol Use Disorder (AUD).
The company said that in the study, dubbed ONWARD, patients on AD04, compared to those on placebo, showed a trend in the reduction from baseline at month six in heavy drinking days for the combined trial population of heavy and very heavy drinkers, but it was influenced by the high placebo response among very heavy drinkers (avg. ?10 drinks per drinking day at baseline), due to both the AD04 and placebo groups reducing mean heavy drinking days by more than 50%.
Adial added that a similar, non-statistically significant trend was seen in the combined months five and six analysis in the reduction from baseline, which was the pre-specified primary efficacy analysis.
The company, however, noted that compared to placebo, AD04 achieved statistically significant mean reduction — from baseline to month six — in heavy drinking days, for a pre-specified patient group (average <10 drinks per drinking day at baseline), which accounted for ~2/3 of the study population.
The company added that in the last month, heavy drinking patients on AD04 had an average reduction of ~79% in heavy drinking compared with baseline.
Adial said AD04 had a safety and tolerability profile which was similar to placebo. More Serious Adverse Events (SAEs) were reported in the placebo group (7) compared to the AD04 group (3). There were two cardiac events in the placebo group and none in the AD04 group.
Adial ( ADIL ) added that it intends to share the results with health authorities to discuss the appropriate next steps towards the expeditious development of AD04 and to seek product approval.
ADIL -25.00% to $1.38 premarket July 20
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Adial stock slumps 25% as AD04 fails to best placebo in very heavy drinkers in trial