On Thursday, Adial Pharmaceuticals Inc (NASDAQ: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 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 six months of treatment.
The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar adverse events profile to a placebo.
Price Action: ADIL shares closed at $1.27 on Tuesday.