Adial Provides Business Update Following Favorable Comments from US and EU Regulatory Meetings

CHARLOTTESVILLE, Va., July 11, 2023 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of AD04, a genetically targeted, serotonin-3 receptor antagonist for the treatment of Alcohol Use Disorder (“AUD”), today provided a summary of feedback received following recent meetings with both US and EU regulators, as well as an update on the Company’s current clinical development plan based on guidance received.

Feedback from the FDA as well as key country-level regulatory agencies in Europe included:

• Acknowledgment and confirmation of the importance of ongoing research in the AUD therapeutic area as a persistent high unmet need.   
• Confirmation of the primary US endpoint based on Percentage of No Heavy Drinking Days (“PNHDD”), which utilized a responder analysis of patients who reduced their alcohol consumption to zero heavy drinking days in the last 2 months of a 6-month study.
• Acknowledgment of results from the Phase 2 and Phase 3 post hoc analysis against the US endpoint of PNHDD, which demonstrated statistical significance of responder analysis of specific genotypes as useful information for planning future studies of AD04.
• Reviewed the safety data from the ONWARD trial and did not express any concerns with the data.
• Confirmation of the importance of identifying a patient subgroup where a relevant treatment effect and compelling evidence of a favorable risk-benefit profile can be assessed.
• Acknowledgment that the post hoc analysis showing a statistical and clinically meaningful effect in specific genetic subtypes was positive and promising. They requested additional data to support an NDA or MA submission and approval for AD04.

“Based on positive feedback received from the relevant global regulatory bodies and overlapping clinical requirements, we made the strategic decision to focus our efforts on the US as the US standards should translate to acceptance in other international markets. We have a high level of confidence that AD04 will achieve success in clinical development based on our post hoc analysis and the regulatory feedback on the pre-specified primary endpoint that the FDA has now confirmed, specifically, a reduction of heavy drinking days to zero at months 5 and 6. This is also vital for our ongoing partnering efforts based on discussions with companies active in the US and Europe. Importantly, the regulators acknowledged the valuable insights of the post hoc analysis, which demonstrated that patients with a specific genetic subtype (AG+), achieved a statistical significance of p=0.031 and p=0.021 respectively in both the Phase 2 and Phase 3 trials. Additionally, these patients averaged over 17 (17.23) heavy drinking days per month at the study start and achieved under 3 (2.37) heavy drinking days per month at study completion. These clinically meaningful results are important as evidenced by the US healthcare provider research completed after the ONWARD trial, which suggests AD04 would play an important role as a medication for physicians currently treating patients with AUD. Also, market research with US payors, completed in 2012 and repeated most recently in 2022, supports AD04 pricing and reimbursement assumptions and confirms AD04 as an attractive commercial opportunity,” stated Cary Claiborne, CEO of Adial Pharmaceuticals.