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Adial Pharmaceuticals Announces Approval to Commence Landmark ONWARD(TM) Pivotal Phase 3 Trial in Sweden and Estonia
CHARLOTTESVILLE, VA / ACCESSWIRE / July 6, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL:ADILW) ("Adial"), a clinical-stage biopharmaceutical company
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"CHARLOTTESVILLE, VA / ACCESSWIRE / July 6, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL:ADILW) (\"Adial\"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received approvals in Sweden and Estonia to commence the Company's landmark ONWARD™ pivotal Phase 3 clinical trial to investigate its lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes. The Swedish Medical Products Agency and Swedish Ethical Review Authority have provided approval for ONWARD™ to commence in Sweden; and the Estonian State Agency of Medicines and Ethics Review Committee overseeing human trials granted approval to commence ONWARD™ in Estonia.\"We are pleased that the regulatory authorities and the ethics committees in Sweden and Estonia have recognized that AD04's safety and efficacy data profile support conducting the ONWARD™ trial in Sweden and Estonia,\" commented William Stilley, Chief Executive Officer of Adial Pharmaceuticals. \"We intend to initiate sites in both countries in the coming weeks. With the relaxing of COVID-19 lockdown restrictions, Adial is working to achieve full operation of ONWARD™ clinical sites as rapidly as possible, with the trial goal to bring a meaningful new treatment for Alcohol Use Disorder to patients in Scandinavia, Eastern Europe and around the world. It is widely reported that the alcohol problem has grown worse during the COVID-19 lockdown, heightening the urgency for pharmacological interventions.\"About Adial Pharmaceuticals, Inc.Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The Company's lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and is currently being investigated in the Company's landmark ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the Company's proprietary companion diagnostic genetic test. A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequ...