Adial Pharmaceuticals(US:ADIL) GlobeNewswire News Room·2024-06-20 12:30Core Insights - Adial Pharmaceuticals published results from its Phase 3 ONWARD study in the European Journal of Internal Medicine, demonstrating the efficacy of AD04 (low-dose ondansetron) in reducing heavy drinking days among patients with Alcohol Use Disorder (AUD) and specific genetic profiles [1][2] Group 1: Study Findings - AD04 significantly decreased the monthly percentage of heavy drinking days after 6 months of treatment among heavy drinking individuals with AUD and a specific genetic profile [2] - The genetic profile involved variants in the serotonin transporter and serotonin-AB receptor complex [2] - Adverse events (AEs) associated with AD04 were comparable to those of the placebo, indicating a favorable safety profile [2][3] - The combination of AD04 with psychosocial interventions may enhance treatment perceptions and increase demand among individuals who might not have sought treatment otherwise [2] Group 2: Implications for Precision Medicine - The findings highlight the potential of AD04 as a precision medicine, emphasizing the importance of genetic and behavioral factors in treating AUD [2] - The study suggests that patients with specific genetic backgrounds who are heavy drinkers experienced a reduction in heavy drinking days after treatment with AD04 [2] - The research indicates that no existing studies in alcohol literature have shown a medication with a similar AE profile to a placebo, underscoring the uniqueness of AD04's safety profile [2] Group 3: Company Overview - Adial Pharmaceuticals is focused on developing treatments for addictions and related disorders, with AD04 being a genetically targeted therapeutic agent for AUD [3] - The ONWARD trial showed promising results in reducing alcohol consumption in heavy drinkers without significant safety concerns [3] - AD04 may also have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [3]