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On Thursday, Adial Pharmaceuticals Inc ADIL 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 (low-dose ondansetron), and the placebo group among heavy drinking patients and specific genotypic variants. Related: EXCLUSIVE: Adial Pharmaceuticals Starts Patient Dosing In Pharmacokinetics Study Of AD04 For Alcohol Use Disorder .
Key findings include: AD04 significantly decreased the monthly percentage of heavy drinking days after six months of treatment among heavy drinking individuals with alcohol use disorder and a specific genetic profile, as determined via a companion diagnostic (CDx). This genotypic profile is in the serotonin transporter and serotonin-AB receptor complex. Additional analysis revealed that patients treated with AD04 experienced minimal adverse events, which were comparable to placebo treatment, high medication compliance, and a minimal dropout rate.
Combining AD04 with psychosocial intervention may change favorably how alcohol use disorder disease is perceived and increase the demand for treatment to many who have not otherwise considered it. The study examined the.
