EXCLUSIVE: Adial Pharma's AD04 Effective In Heavy Drinker Alcohol Use Disorder Patients

Zinger Key Points
  • Adial's Phase 3 results demonstrate the effectiveness of AD04 for heavy drinker AUD patients.
  • The company plans to submit the results to both European and U.S. regulatory agencies.

Adial Pharmaceuticals Inc's ADIL ONWARD Phase 3 study of AD04 for Alcohol Use Disorder (AUD) achieved a statistically significant mean reduction in heavy drinking days compared to placebo.

Trial Results: AD04 achieved a statistically significant mean reduction compared to placebo from baseline at month six in heavy drinking days among "heavy drinkers" (average <10 drinks per drinking day), accounting for around two-thirds of the trial population. 

A similar trend was seen in the combined month five and six analysis. Notably, AD04 heavy drinking patients had a mean reduction of approximately 79% in the last month of the trial compared with baseline.

AD04 also showed safety and tolerability that compared favorably to placebo. 

AD04 patients showed a trend in the reduction at month six in heavy drinking days for a combined group of heavy and very heavy drinkers, influenced by the high placebo response among very heavy drinkers (avg. ≥10 drinks per drinking day), due to both the AD04 and placebo groups reducing mean heavy drinking days by over 50%. 

A similar, non-statistically significant trend was seen in the combined months five and six analysis.

AD04 patients in the heavy drinking group had an overall significant difference in the severity of their AUD diagnosis compared to placebo (27.4% vs. 14.9%), equivalent to an 84% decrease.

William Stilley, the CEO, told Benzinga, "These results provide hope for the tens of millions suffering from AUD and their loved ones."

"With favorable safety and side effect findings similar to placebo, we believe AD04 would have a widespread appeal within a market valued in the tens of billions of dollars in the US alone," Stilley added.

What's Next: Adial intends to share the results of the ONWARD trial with the relevant health authorities to discuss the appropriate next steps toward the development of AD04.

The company is also planning to explore strategic partnerships.

Price Action: ADIL shares are up 9.24% at $2.01 during the premarket session on the last check Wednesday.

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