Adial Pharmaceuticals announces publication on efficacy of AD04

Adial Pharmaceuticals announced the publication of previously disclosed results from its Phase 3 ONWARD study in a peer-reviewed article in the European Journal of Internal Medicine entitled, “Low-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes.” The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the Company’s lead asset, AD04, and the placebo group among heavy drinking patients with Alcohol Use Disorder and specific genotypic variants. Key findings include: AD04 significantly decreased the monthly percentage of heavy drinking days after 6 months of treatment among heavy drinking individuals with alcohol use disorder and a specific genetic profile, as determined via a CDx; This genotypic profile is in the serotonin transporter and serotonin-AB receptor complex; AD04s adverse events match those of the placebo; Combining AD04 with psychosocial intervention may change favorably how AUD disease is perceived and increase the demand for treatment to many who not have otherwise considered it. The study examined the role of endophenotypes in predicting AD04’s efficacy for the treatment of AUD and found that specific genotypes affecting the serotonin transporter and serotonin-AB receptor complex are predictive of AD04’s ability to reduce the number of heavy drinking days among patients with AUD. In particular, the data revealed that individuals with specific genetic backgrounds and meeting the criteria to be defined as “heavy drinkers” saw a reduction in the monthly percentage of heavy drinking days after 6 months of treatment. Additional analysis revealed that patients treated with AD04 experienced minimal AEs which were comparable to placebo treatment, high medication compliance, and a minimal dropout rate. The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar AE profile to a placebo.