Adial moves forward with AD04 clinical trial for AUD

To begin with, AD04 is low‐dose ondansetron, combined with behavioral counseling. But it's patented, and only being investigated for certain patients (who test positive for a certain genotype). The “Onward” Phase 3 clinical trial for a new treatment for alcohol use disorder (AUD) for people with certain genotypes is moving forward, with 90% of target patients enrolled, the company announced July 6. The genotypes are related to the serotonin transporter and receptor genes. So far, 1,254 subjects have been screened, and 261 of the anticipated 290 subjects have been enrolled. Of evaluated patients, 33% tested positive for the AD04‐associated genotype. AD04 is ondansetron, a nausea medication, but with a much smaller dose. ADAW interviewed Bankole Johnson, M.D., for the March 25, 2019, issue when he was still chair of the Department of Psychiatry at the University of Maryland and was working on AD04 and on the board of directors of Adial. At the time, he warned against patients trying to take a lower dose of ondansetron, and also of patent infringement for anyone considering prescribing it for AUD. The week after our interview, he resigned from the university and became chief medical officer of Adial. 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, according to Adial. Much of the press information from the company is directed toward investors.