Adial Pharmaceuticals provides update on Phase III ONWARD trial of AD 04 to treat Alcohol Use Disorder.
Adial Pharmaceuticals, Inc. provided an update on its landmark ONWARD Phase III pivotal trial of its lead drug candidate, AD 04 in genetically identified subjects for the treatment of Alcohol Use Disorder (AUD).
“Adial expects to enroll 294 trial subjects for ONWARD . To date, 30 trial subjects have been recruited and 8 of these subjects have satisfied trial screening criteria, including our companion genetic test, and patient dosing began in March,” commented William Stilley, CEO of Adial Pharmaceuticals. “ONWARD is progressing during the COVID-19 pandemic with certain trial enhancements and modifications to move the trial forward diligently while reducing the potential exposure of trial subjects.”
ONWARD has been adapted to incorporate the use of tele-medicine and has reduced in-clinic visits and non-essential procedures: Site initiation visits are now being conducted by video conference, and interim monitoring visits will also be conducted by video conference. The number of in-clinic visits per subject has been reduced from 19 to 8. Five in-clinic visits per subject have been replaced with tele-medicine safety and efficacy assessments and behavioral treatments. The duration of in-clinic visits has been shortened by eliminating non-essential procedures.
Changes are not expected to negatively impact ONWARD reaching its primary end-points. Adial expects these changes to increase ONWARD subject retention rates due to the reduced in-person attendance requirements and to mitigate the placebo effect in the trial due to fewer in-person counseling sessions, both of which would be expected to enhance the statistical strength of the trial.
Regulatory approvals to commence ONWARD have been received for a number of countries. In order to commence the trial in each country, approval must be received by the country’s Central Authority (CA) and Ethics Committee (EC).
Mr. Stilley concluded, “Even though the COVID-19 related delays are expected to extend the time to receive trial data by several weeks, we are making steady progress, and more than 25% of trial subjects screened to date have been qualified, exceeding our projections. Additionally, our cash burn has been reduced as a result of the changes. We continue to carefully manage our expenses, and remain confident we can complete the ONWARD trial without raising additional dilutive financing.”.