Adial Pharmaceuticals (ADIL) has announced positive results from its AD04-103 pharmacokinetics (PK) study, evaluating AD04 for the treatment of Alcohol Use Disorder (AUD). The study confirms predictable bioavailability, dose proportionality, and no food effect, with a safety profile consistent with ondansetron.
The AD04-103 study, which included 30 healthy volunteers, was designed to assess the pharmacokinetics, bioavailability, and food effect of AD04 relative to marketed ondansetron. The results showed that ondansetron exposure increased proportionally across a threefold AD04 dose range, between 0.33 mg and 0.99 mg tablets, comparable to a 4 mg dose of ondansetron.
Key Findings of the AD04-103 Study
The AD04-103 study was conducted in two cohorts:
- Cohort 1 (n=6): Assessed PK variability at 0.33 mg and 0.99 mg doses.
- Cohort 2 (n=24): Evaluated bioavailability vs. ondansetron 4 mg, dose proportionality, and food effect.
The study confirmed that AD04 can be administered with or without food, a significant advantage for patient compliance. Cary Claiborne, CEO of Adial, stated, "This study supports our plans to seek FDA approval under the 505(b)(2) pathway."
AD04 and the 5-HT3 Pathway
AD04 is a selective 5-HT3 receptor antagonist designed for patients with specific 5-HT3 receptor mutations (SNPs rs1150226-AG or rs1176713-GG). These mutations may enhance drug binding and efficacy. Adial has developed a Companion Diagnostic Test (CDx) to identify patients most likely to benefit from AD04, which was successfully used in the ONWARD trial.
Next Steps for AD04
Adial plans to incorporate the FDA's feedback from the PK bridging study as they prepare for their End-of-Phase 2 meeting, targeted for the first half of this year. The company is also exploring external collaborations for both development and commercialization, leveraging these findings to advance AD04’s clinical and market readiness. These efforts position the drug for meaningful progress toward FDA approval and broader adoption for AUD treatment.
