EXCLUSIVE: Adial Pharmaceuticals Reveals Positive Pharmacokinetics Study Results Of AD04 For Alcohol Use Disorder

On Wednesday, Adial Pharmaceuticals ADIL announced the completion of the AD04-103 pharmacokinetics (PK) study for AD04, confirming predictable bioavailability, dose proportionality, no food effect, and a safety profile consistent with ondansetron's use.

These results enable an End-of-Phase 2 (EOP2) FDA interaction to finalize the Phase 3 trial design and support ongoing partnership discussions.

AD04, a selective 5-HT3 antagonist for Alcohol Use Disorder (AUD), is being developed for patients with a 5-HT3 genomic biomarker and follows a micro-dosing regimen under the FDA's 505(b)(2) pathway.

Study AD04-103 Highlights:

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.

Results confirmed ondansetron exposure increased proportionally across AD04 doses and can be taken with or without food.

Related: Adial Pharmaceuticals Reveals Topline Results From Pharmacokinetics Study Of AD04 For Alcohol Use Disorder  

Cary Claiborne, CEO, stated, "This study supports our plans to seek FDA approval under the 505(b)(2) pathway. We have engaged with the FDA on the results of this PK bridging study and will incorporate their feedback as we prepare for our End-of-Phase 2 meeting, targeted to take place in the first half of this year. We are excited to achieve this important milestone on the path toward regulatory approval."

AD04 is designed for patients with specific 5-HT3 receptor mutations (SNPs rs1150226-AG or rs1176713-GG), which 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 and planned for future FDA approval and commercialization.

Price Action: At the last check on Wednesday, ADIL shares were trading higher by 3.73% at $0.86 premarket.