Medication to Treat Alcohol Use Disorder Shows Promise in Phase 3 Trial

Adial Pharmaceuticals, a clinical-stage biopharmaceutical company that develops therapies to treat and prevent addiction and related disorders, announced that in its ONWARD Phase 3 clinical study, its AD04 medication achieved a statistically significant mean reduction in heavy drinking days among a prespecified group of “heavy drinkers” compared to a placebo.

Adial conducted the ONWARD trial to evaluate the efficacy, safety, and tolerability of AD04 in patients diagnosed with alcohol use disorder and selected polymorphisms in the serotonin transporter and receptor genes. The study was conducted in 25 clinical sites in 6 countries in Scandinavia and central and eastern Europe.

AD04 reduced baseline drinking in the prespecified group by approximately 79% by the last month of the trial and produced an 84% decrease in the number of heavy drinking patients with alcohol use disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

AD04 was also found to have safety and tolerability that compared favorably to the placebo, with no serious adverse events (SAEs) determined to be related to AD04 treatment and fewer SAEs reported than the number reported in the placebo group.

“Alcohol use disorder is an unmet medical need that affects tens of millions of people each year, and, based on the strength of these ONWARD results in heavy drinking patients that have the target genetics, and the fact that AD04 demonstrated an exceptional safety profile, and was well-tolerated during the trial, we intend to advance AD04,” Adial CEO William Stilley said in a news release.

“We will work with regulatory authorities in Europe and the US to achieve this goal. We also plan to explore strategic partnerships.”

In its news release announcing the study results, Adial said plans to submit its findings to both European and US regulatory agencies to discuss next steps toward development of AD04 and, ultimately, product approval.

Reference

Adial Pharmaceuticals announces topline results for ONWARD phase 3 trial for AD04 in patients with alcohol use disorder. News release. Adial Pharmaceuticals. July 20, 2022. Accessed July 28, 2022.