Adial Pharmaceuticals Achieves 50% Enrollment in ONWARD Phase 3 Trial

CHARLOTTESVILLE, Va., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that it has reached 50% enrollment in the Company’s landmark ONWARD pivotal Phase 3 clinical trial. 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.

“We are pleased to have achieved this important enrollment milestone in our ONWARD pivotal Phase 3 clinical trial,” stated Schuyler Vinzant, Adial’s Vice President of Development. “We have a high degree of confidence that ONWARD will be fully enrolled this summer.”

Data Points – ONWARD Trial Patients

• 66% of planned patient screening visits completed
  • 830 patients screened out of 1,254 patients expected to be required to achieve full enrollment (more than 20 screened patients are currently pending enrollment)

• 32% of patients screened are genetically positive for treatment with AD04
  • Percentage of genetically positive patients consistent with Phase 2b prevalence and expected U.S. and European prevalence

• 75% of patients screened as genetically positive have been enrolled
  • Patient enrollment exceeds projected rate of 50% for genetically positive patients

• 86% ONWARD patient retention rate to date
  • Retention rate significantly greater than projected 70% retention rate

William Stilley, Adial’s Chief Executive Officer, commenting on the ONWARD trial protocol, stated “Telephonic pre-screening of potential study patients has allowed us to successfully reduce non-genetic screen failure rates. Moreover, streamlined site visits and patient follow-up processes have resulted in better-than-expected retention rates to date.”

Mr. Stilley continued, “Adial would like to express its genuine gratitude to all the ONWARD patients for their participation in the study and appreciation for the commitment they have made. We also appreciate the hard work of the more than 50 incredible frontline healthcare workers, including doctors, nurses and their staff, who are caring for our patients and share Adial’s commitment to improving outcomes for people suffering from Alcohol Use Disorder.”