Adial Pharmaceuticals provides an update on its ONWARD pivotal phase III trial of AD 04 for treatment of alcohol use disorder.

Adial Pharmaceuticals, Inc. provided an update on its landmark ONWARD Phase III pivotal trial. ONWARD is investigating Adial's lead drug candidate, AD 04, 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. William Stilley, Chief Executive Officer of Adial Pharmaceuticals said "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".l