Business
Adial Pharmaceuticals Provides Update on its ONWARD(TM) Pivotal Phase 3 Trial of AD04 for Treatment of Alcohol Use Disorder
ONWARD™ Projected to be Fully Enrolled During Q2 2021 CHARLOTTESVILLE, VA / ACCESSWIRE / November 3, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW),
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"ONWARD™ Projected to be Fully Enrolled During Q2 2021 CHARLOTTESVILLE, VA / ACCESSWIRE / November 3, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD™ Phase 3 pivotal trial. ONWARD™ is investigating 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.Key ONWARD™ highlights include:All 25 planned investigative sites are active.40% of expected Trial patient screenings have been completed and the Trial is more than 25% enrolled relative to planned enrollment.The enrollment rate has increased for four consecutive months and the Trial is projected to be fully enrolled during Q2 2021.Data readout is expected in Q4 2021 or earlier.AD04 has been well tolerated with no serious adverse events having been reported.\"We are encouraged by the steady progress of our ONWARD™ Phase 3 trial and we are on track to complete enrollment during Q2 2021,\" commented William Stilley, Chief Executive Officer of Adial Pharmaceuticals. \"AUD accounts for nearly six percent of all deaths worldwide and is the leading cause of death among men and women in their prime (ages 15 to 49). AUD also represents a dramatically underserved market, as current therapies have limited efficacy and significant side effects. We believe AD04 may represent a paradigm shift in treating this population. Among patients with the target genotype, we estimate the market for AD04 to be in excess of $35 billion in the United States where we are pursuing expedited review programs for AD04. The European market is expected to be similar in size. It has also been reported that the AUD crisis continues to escalate given the prolonged nature of the COVID-19 pandemic. We remain determined to advance ONWARD™ and look forward to providing further updates as we achieve key milestones.\"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 therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and...