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Adial Pharmaceuticals Provides Update on Regulatory Strategy for AD04 for Treatment of Alcohol Use Disorder
Company to pursue path toward U.S. and European approvals; Type C meeting with FDA confirmed for Q2 2023; plans in place to meet with multiple European
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":" Company to pursue path toward U.S. and European approvals; Type C meeting with FDA confirmed for Q2 2023; plans in place to meet with multiple European regulatory authorities Adial in discussions with potential pharma partners Conference call to be held at 8:15 a.m. EST tomorrow CHARLOTTESVILLE, Va., March 06, 2023 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”) a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided an update on its regulatory strategy for AD04, the Company’s lead compound for the treatment of Alcohol Use Disorder (AUD). Key highlights: Additional analysis of ONWARD™ data identified specific genotypes that outperformed othersType C meeting with FDA confirmed for Q2 2023 to discuss clinical program in U.S.Meetings scheduled or planned with five European country-level regulatory authoritiesAdvancing discussions with potential U.S. and European partnersMarket research commissioned by Adial subsequent to completion of the ONWARD trial suggests unit pricing for AD04 could be more than double the previous assumptions Adial’s lead compound, AD04, is a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and was recently investigated in a Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which were identified using the Company’s companion diagnostic genetic test. ONWARD results showed that AD04 achieved a statistically significant reduction of heavy drinking days in a subgroup of patients - the “heavy drinkers.” The “heavy drinker” population, defined as patients who drank fewer than 10 drinks per drinking day prior to enrollment, accounted for approximately two-thirds of the trial population. Based on the ONWARD trial results, and after discussions with its regulatory advisors and key opinion leaders (KOLs), Adial believes there is a clear, cost-effective path toward FDA approval that it plans to aggressively pursue. This decision was based on a detailed analysis of both the prior Phase 2 clinical trial and the recently completed ONWARD Phase 3 clinical trial. These results were reviewed with regulatory and statistical experts to confirm their validity. Additionally, after these resul...