Adial Pharmaceuticals Publishes Evidence Supporting AD04 for Alcohol Use Disorder Treatment

Adial Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has made a significant stride in the treatment of Alcohol Use Disorder (AUD). The firm recently announced the publication of results from its Phase 3 ONWARD study in the European Journal of Internal Medicine. The study, titled "Low-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes," showcased the potential of AD04, a low-dose ondansetron, in reducing heavy drinking days among patients with AUD who have certain genetic profiles.

The ONWARD study focused on individuals with AUD and specific genotypic variants, specifically in the serotonin transporter and serotonin-AB receptor complex. Results indicated that AD04 can significantly reduce the monthly percentage of heavy drinking days after six months of treatment in these individuals. This reduction was noteworthy when compared to the placebo group. The study's findings also highlighted that AD04’s adverse events were similar to those of the placebo, suggesting a favorable safety profile.

AD04's precision medicine approach, which combines genetic profiling via a companion diagnostic test (CDx), underscores a shift towards more personalized treatments for AUD. Cary Claiborne, CEO of Adial, emphasized the importance of this method. He stated that AUD is influenced by various gene-environment interactions and does not present uniformly across all patients. Claiborne believes that AD04 offers a more effective treatment option tailored to individual genetic profiles, moving away from a generic treatment model.

The study analyzed the role of endophenotypes in predicting the efficacy of AD04. It concluded that specific genotypes affecting the serotonin transporter and serotonin-AB receptor complex are indicative of AD04’s ability to reduce heavy drinking days among AUD patients. The data showed that individuals with these specific genetic backgrounds, who are categorized as heavy drinkers, experienced a marked reduction in heavy drinking days after six months of treatment with AD04.

The findings also highlighted that patients treated with AD04 experienced minimal adverse events, on par with those seen in the placebo group, indicating a high safety and tolerability profile. Medication compliance among participants was high, with a minimal dropout rate, reinforcing the potential of AD04 as a viable treatment option. The authors noted the uniqueness of AD04, as no other effective medication for AUD has demonstrated a similar adverse event profile to a placebo.

Adial Pharmaceuticals focuses on developing treatments for addictions and related disorders. AD04, the company's lead investigational drug, is a serotonin-3 receptor antagonist targeted at treating AUD in heavy drinking patients. The ONWARD study, a pivotal Phase 3 clinical trial, showed promising results in reducing heavy drinking days in patients with specific genotypes identified through Adial’s companion diagnostic genetic test. The study did not raise any significant safety or tolerability concerns.

In addition to its potential in treating AUD, AD04 may also be effective for other addictive disorders, including Opioid Use Disorder, gambling, and obesity. This broader applicability underscores the significance of AD04 in the landscape of addiction treatment. Adial Pharmaceuticals remains committed to advancing its research and bringing innovative solutions to those struggling with addiction disorders.