Benzinga | Jul 6, 2021 09:27AM EDT

Adial Pharmaceuticals Says Phase 3 ONWARD Trial Meets Screening Target, Nears Enrollment Completion

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW))))), a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today announced that the Company has made significant progress on its pivotal ONWARD Phase 3 clinical trial having met 100% of its patient screening target and having achieved 90% of its patient enrollment target. The ONWARD trial is evaluating 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.

ONWARD Trial Recent highlights:

* 100% of the number of patients expected to fully enroll ONWARD have been screened 1254 subjects have been screened which represents 100% of anticipated subjects required to be screened based on the trial's historical screening-to-enrollment rates

* 90% of the number of patients projected for full enrollment have been enrolled 261 of 290 (90%) subjects expected to be enrolled in ONWARD have been enrolled

* 33% of evaluated patients tested positive for the AD04-associated genotype This genetic data is consistent with Adial's expectations for U.S. prevalence of the target genotype and supports current addressable market forecasts for AD04, estimated at $36 billion and growing

* AD04 appears to be well-tolerated While the trial is still blinded so it is not known which patients are taking AD04 or placebo, the vast majority of adverse events reported across all study subjects are mild in intensity No trial study drug-related serious adverse events have been observed to date

* Study retention rate of 84% continues to exceed expectations The 84% study retention rate continues to outpace the projected 70% retention rate The high retention rate is consistent with the encouraging safety data observed and the Company believes retention is correlated with AD04's tolerance.

"We are on track to deliver trial data in the first quarter of 2022," said Schuyler Vinzant, Adial's Vice President of Development.

William Stilley, Adial's Chief Executive Officer, commented, "Full trial enrollment is expected in the coming weeks as we drive toward generating data from ONWARD as we advance our science with the goal of bringing help to those with addiction. The ramifications for all addictions, and even other mental health disorders, could be powerful and significant."