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Adial Pharmaceuticals Reaches 35% Enrollment in ONWARD(TM) Pivotal Phase 3 Trial of AD04 for the Treatment of Alcohol Use Disorder
ONWARD™ Trial Remains on Track to be Fully Enrolled During Q2 2021 CHARLOTTESVILLE, VA / ACCESSWIRE / December 17, 2020 / Adial Pharmaceuticals, Inc.
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"ONWARD™ Trial Remains on Track to be Fully Enrolled During Q2 2021 CHARLOTTESVILLE, VA / ACCESSWIRE / December 17, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced it has reached the 35% enrollment target in the Company's landmark ONWARD™ Phase 3 pivotal trial in Europe. ONWARD™ is investigating the efficacy and safety of Adial's 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.William Stilley, Chief Executive Officer of Adial Pharmaceuticals, commented, \"Reaching the 35% enrollment target reaffirms the continued progress in our ONWARD™ Phase 3 trial in Europe. Additionally, there has been an uptick in screenings, and, based on our enrollment rates to date, we anticipate having the ONWARD trial 50% enrolled in the next month. We are encouraged that the early termination rate is lower than we had expected. Importantly, there have been no serious adverse events to date. We are also adding additional sites in high enrolling countries, which we believe will further enhance the trial enrollment. In response to the COVID-19 pandemic, a protocol amendment was successfully implemented at all sites to incorporate remote procedures and reduce clinical trial participant time on site. As a result, we remain on track to complete enrollment by the second quarter of 2021 and look forward to providing further updates as we advance the trial.\"\"We are especially proud to achieve these milestones on schedule, despite the impact of COVID-19 on clinical trials around the globe, and we remain fully committed to advancing our goal of bringing this meaningful new treatment for AUD to patients worldwide. Today, there is no adequate treatment for AUD as current therapies have limited efficacy and significant side effects. It is widely reported that the alcohol problem has grown worse during the COVID-19 lockdown, heightening the urgency for pharmacological interventions such as AD04.\"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 pro...